Criminal Complaint vs. SwissMedic/mRNA Vax

Swiss Lawyer Philipp Kruse provides a comprehensive summary of mRNA "vaccine" regulatory failures and lies

On July 14, 2022, Philipp Kruse filed a carefully worded comprehensive legal complaint against the Swiss Regulatory authority known as Swissmedic for their role in enabling deployment of the COVID mRNA “vaccines” into the population of Switzerland. On 28 March 2024, the complaint was refiled with substantial updates and amendments. This complaint provides a comprehensive summary of the case against the official regulatory positions and activities promoted by Swissmedic, which closely parallel those taken by the US FDA, Health Canada, the European Medicines Agency and most other national regulatory authorities.

Swissmedic is the Swiss Agency for Therapeutic Products. More precisely, Swissmedic is the Swiss surveillance authority for medicines and medical devices, and is registered in Bern, Switzerland. Swissmedic fulfills a Swiss federal mission similar to the US HHS Food and Drug Agency (FDA).

Key complaints detailed in this filing include the following criminal acts, which appear to apply equally to many other national regulatory authorities:

Criminal acts performed by Swissmedic

1. Initial authorization that breaches the law and duties

2. Perpetuation of illegal authorizations that breach the law and duties

   1. Disregard for all additional indications of risk

   2. Absence of a "life-threatening or debilitating" disease

   3. No benefits from ineffective to harmful mRNA injections

   4. Omission of the most elementary safety and effectiveness tests

   5. Swissmedic blocked effective alternative treatments

   6. Benefit-risk analysis – Clearly a negative profile

   7. Continuing despite an obviously negative benefit-risk ratio

3. No product monitoring proportionate to the risks

4. Misleading information not proportionate to the risks

5. Medical malpractice – lack of information, lack of reports

6. Swissmedic out of control and acting to the detriment of the state and the

   population

As summarized in his “X” bio (see image above and his academic CV which can be viewed here), Mr. Kruse is an experienced Swiss and International Law specialist. Having filed this legal complaint, he posted a PDF copy on “X” for download and review, promptly resulting in “X” designating his account “Temporarily Restricted” due to “unusual activity”.

UPDATE: Due to the censorship of the prior account, Philipp Kruse has now established a new “X” account at @KruseLawyer

I first met Mr. Kruse while visiting Stockholm to lecture on the COVIDcrisis and fifth generation warfare, and he told me of the legal case he was about to file in Switzerland regarding the governmental mismanagement of the response to COVID. Impressed with his knowledge of international law, I invited him to speak at the most recent Senator Johnson hearing in the US Senate regarding his understanding of the legal underpinnings of the proposed WHO pandemic treaty and International Health Regulation modifications. Below is a video of his brief testimony. As you can sense from the video, Mr. Kruse is a very meticulous, detail-oriented and fundamentally conservative (in the classical sense- cautious and non-flamboyant in demeanor and actions) Swiss attorney. He is committed to respect for human rights, but is certainly not a wild-eyed far-right radical. His positions are carefully researched and documented.

Mr. Kruse and his colleagues have addressed their reasons for taking these actions in a press release dated 24 March 2024.

Criminal complaint 2.0 against Swissmedic filed Zurich, 28 March 2024 –

In the name of and on behalf of six persons directly injured by mRNA vaccinations and for other persons, we hereby publish our criminal complaint against the Swiss regulatory authority Swissmedic and against vaccinating physicians ("Criminal complaint 2.0"), which has be filed on 7 February 2024 after comprehensive factual and legal updates, supplementation and clarification. This step became necessary because, since the first criminal complaint was filed on 14 July 2022, the legally relevant evidence had not only been fully confirmed in terms of the facts presented and the legal arguments, but had also been accentuated and aggravated in most cases. At the same time, the reported criminal activities were consistently continued by Swissmedic, without any sign of any constitutional correction on the part of the Swiss judiciary or the Swiss Parliament (Art. 169 et seq. Federal Constitution) - on the contrary: With the draft revision of the Epidemics Act, the Federal Council wants to further expand the current practice of emergency authorizations and the use of novel, experimental vaccines.

What's new?

Compared to the first version dated 14 July 2022, the criminal complaint 2.0 contains updated, supplemented and improved legally relevant evidence up to mid-2023 (in some cases beyond) and also comprehensively supplemented and clarified legal explanations, including with regard to

- Evidence that at no time was there a discernible threat to public health from SARSCoV-2 in the form of a debilitating or life-threatening disease within the meaning of Art. 9a para. 1 TPA;

- Evidence that available and long-established alternative prevention and treatment methods have been ignored by Swissmedic to date;

- Evidence that mRNA-based injections pose a particular risk to human health, especially that of children and adolescents (alarming mortality data and declining birth rates);

- Proof of the special experimental character of the mRNA-based preparations; - Evidence that a positive benefit/risk ratio of mRNA-based Covid-19 "vaccinations" was never proven;

- Extensive evidence that Swissmedic has consistently and permanently misled the entire population and Swiss key decision-makers regarding the actual risk content of mRNA preparations and the lack of evidence of a protective effect with regard to infection and transmission, which is why a criminal investigation into the offense of falsification of documents in office (Art. 317 SCC) can no longer be postponed.

Motive for new publication

As a consequence of the completion of our investigation since the end of 2021 (i.e. work by a larger team of both internal staff and a group of pro bono supporting scientists), there can no longer be any reasonable doubt that the risk to public health from mRNA substances, already sufficiently clearly demonstrated by the criminal complaint of 14 July 2022, is greater than that from SARS-CoV-2, and that this risk created by authorities continues to exist. For this reason, because Swissmedic is pursuing unperturbed it’s criminal behavior. Therefore, and because it is doing exactly the opposite of what Switzerland's highest authority for drug safety would be obliged to do by law, we feel compelled to make this criminal complaint 2.0 submitted on 7 February 2024 freely accessible to the public - and thus to all members of the Swiss Federal Assembly – ultimately to protect the public from high risk mRNA-based medicinal products and from misleading, deceptive information about the effective risk associated with the authorized mRNA-substances.

I suggest that the legal complaint which Mr. Kruse has compiled and submitted to Swiss legal authorities is the most comprehensive summary of the regulatory mismanagement and fraud which has taken place at virtually all western national regulatory authorities during the push for mandatory deployment and uptake of the COVID mRNA “vaccines”, and can serve as a template for both other complaints as well as expert witness testimony. Furthermore, I am struck by the parallels between the actions of the Swiss national regulatory authority, the US FDA/CDC, and virtually all other western national regulatory authorities. This strongly suggests close communication and/or collusion among these agencies and their political and bureaucratic State managers during the COVIDcrisis.

With that in mind, I have included key sections from the executive summary of the complaint below. A PDF copy of the full executive summary can be found here (independent archive) and here, and the press release together with both the summary and the full 450 page complaint document can be found here.

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Swissmedic criminal claim – "Executive Summary" (2.0)

(redacted for general legibility)

"All things are poison, and nothing is without poison; it is but the dosage that

makes a thing not poison."

(Paracelsus [1493-1541], Swiss physician, alchemist and philosopher)

"Any person handling therapeutic products must take all measures necessary according to the state of the art to ensure that human or animal health is not endangered."

(Art. 3, Federal Act on Medicinal Products and Medical Devices, Therapeutic

Products Act, TPA).

Suspicion

In the present case, we are dealing with the greatest danger to and violation of human health caused by medicinal products themselves and by misinformation from public officials in this regard that has ever occurred in the history of Switzerland. The mRNA "vaccines" against SARS-CoV-2 infections, which are largely ineffective and pose an above-average risk to human health, have been proven to pose a far greater threat to the healthy population than the SARS-CoV-2 pathogen itself, against which these "vaccines" were supposed to protect.

Swissmedic, or the persons acting on its behalf, are primarily responsible for the violation of human health already caused by mRNA-based substances and for the ensuing threat.

By law, Swissmedic is tasked with protecting the health of the Swiss population against ineffective or harmful medicinal products. According to the Swiss Therapeutic Products Act (TPA), it is obliged, on the one hand, to ensure that only high-quality, safe and effective therapeutic products are placed on the market. On the other hand, it must protect consumers of therapeutic products against fraud in this context (Art. 1 TPA). Other clear legal obligations as well as these were repeatedly and significantly not fulfilled by those acting on behalf of Swissmedic to the detriment of the injured persons making a report, which is why they have been under urgent suspicion from December 2020 until today.

• given that they, in the context of authorization, manufacture and batch testing and import, repeatedly breached the due diligence requirements under therapeutic products law.

• by granting a "temporary" marketing authorization for various mRNA-based preparations reserved only for special emergency situations in accordance with Art. 9a TPA for various mRNA-based preparations without need, maintaining them permanently and extending their scope of application to all age groups, although it was already adequately proven at the time of the initial authorization that a COVID-19 infection was neither "life-threatening" nor "debilitating" for the healthy population under 65 years of age within the meaning of the Therapeutic Products Act (and that even for those over 65 years of age a conspicuous mortality rate could only be established during short phases in 2020 – albeit without any evidence of a causal link with SARS-CoV-2

• by granting this de facto emergency authorization under Art. 9a TPA without actual need, maintaining this de facto emergency authorization permanently and extending its scope of application to all age groups, although suitable alternative treatment protocols were already available in the course of 2020 (N 1104 ff.),

• by granting – within the meaning of the TPA – the authorization of the mRNA "vaccines" under "temporary authorizations" in accordance with Art. 9a TPA despite the lack of sufficient proof of effectiveness, despite massive indications of risk and despite the absence of a life-threatening or debilitating disease for the population as a whole,

• by massively undercutting the already very low safety requirements applicable to the procedure under Art. 9a TPA, outside of the scope of their dutiful discretion instead of respecting the mandatory and otherwise usual requirements of the ordinary authorization procedure under the guise of "pandemic authorizations", thereby creating additional risks to public health that had never before been posed by a medicinal product,

• by, instead of carrying out a comprehensive risk-benefit analysis (N 807 ff.) and immediately revoking the authorizations or at least allowing the granted authorizations to expire, renewing their decision to act at the end of 2022 (i.e. having long since been against their better judgement) and perpetuating the new, still experimental mRNA therapy/prophylaxis from 2023 in the sole interest of the manufacturers as a new platform for broad-based use by means of allegedly "ordinary" authorizations,

• by not only permanently withholding key information from the public and the medical profession on the minimal to non-existent protective effect of the mRNA "vaccines" and on the actual risks of side effects, but also by permanently and systematically disseminating misleading information on these issues,

• of having failed to fulfill the obligation to monitor the product after marketing authorization (so-called "pharmacovigilance") in a manner that was proportionate to the risks involved, and instead seriously and permanently violated the obligation to provide notification of side effects under therapeutic product law (Art. 87 para. 1 lit. c TPA),

• of having seriously violated the prohibition on the advertising of medicinal products under therapeutic product law (Art. 87 para. 1 lit. b TPA),

• of having fulfilled the relevant elements of the Criminal Code ( N 1457 ff.) with respect to the undesirable side effects (death, damage to health) that were foreseeable from the authorization studies and then occurred after authorization,

• of having knowingly and persistently misled both the public and medical professionals in a criminal manner about facts that are essential for the risk-benefit assessment when making a vaccination decision (in particular: forgery of a document by a public official, Art. 317 SCC, N 1198 ff., 1427 ff.; see also ER N 1964 et seq., in particular).

Criminal acts performed by Swissmedic

Initial authorization that breaches the law and duties

The breaches of the law and duty of due diligence objected to here essentially consist of the fact that the authorized persons acting on behalf of Swissmedic provisionally authorized mRNA medicinal products for preventive purposes "on a temporary basis" within the meaning of Art. 9a TPA, although Swissmedic must have been aware of countless risk factors as early as December 2020, each of which would have individually stood in the way of granting a "temporary" authorization until the corresponding risk factors had been thoroughly clarified and eliminated under normal circumstances. The following should be emphasized at this point (for information on many other risk factors, see N 1291 ff.):

• The mRNA COVID-19 vaccines are based on the same mode of action as gene therapies and have therefore been categorized by regulators such as Swissmedic and the European Medicine Agency (EMA) as well as by the manufacturers themselves as an "Advance Therapy Medicinal Product" (ATMP), which poses a particular risk for the following reasons:

1. Until the end of 2020, mRNA technology had only been used in cancer patients at the pre-mortem stage, i.e. only to combat an existing life-threatening disease, but

   had never before been used purely prophylactically to immunize an entire healthy

   population (N 186 ff.; ER N 62, N 67 ff.). Compared to all other medicinal products

   that have been authorized to date, either on an ordinary or "temporary" basis, the

   authorization of this mRNA technology as an alleged "vaccine" for healthy people is completely unprecedented and therefore represents a considerable risk.

2. The mRNA technology used here is characterized by the fact that the production

   process of the actual immunizing active substance (active pharmaceutical ingredient = the spike protein) is transferred into the human body. The end product of this internal "vaccine production" is completely unknown in terms of dosage and quality. To date, there is still not sufficient empirical data available to show that the body's own production of the spike protein can be controlled: (1) quantity of endogenous production; (2) duration of spike production; (3) location of production in the body (affected organs; (4) quality of the proteins produced; and with regard to (5) effectiveness and safety of the active substance produced for a healthy population treated purely prophylactically. The administration of a substance that proves to be uncontrollable with regard to all pharmaceutically relevant parameters must by definition be deemed an experiment on humans.

3. Both the Federal Office for the Environment and Swissmedic were aware of the particular problems associated with mRNA substances and recognized that these mRNA active substances are gene-modified organisms

   (GMOs/GMMOs) and Advanced Therapy Medicinal Products (ATMPs). In doing

   so, they implicitly recognized that both the Gene Technology Act must be observed and that, above all, the authorization of these products following the simplified authorization procedure would have been ruled out.

• In addition, Swissmedic abandoned the requirements for a standardized dosage of the (mRNA) preparations authorized for injection that are otherwise mandatory for all other medicinal products. For example, Swissmedic accepted an mRNA content per dosage in an arbitrarily wide range of 37% – 126% of the amount of active substance formally declared by the manufacturer, disregarding the most basic standards. Swissmedic thus accepted the corresponding risks of a high proportion of non-intact mRNA and a considerable risk of genotoxicity and carcinogenicity. The same applies to other toxic impurities such as nitrosamine and benzene.

• The manufacturing process for the mRNA products actually administered ("manufacturing process 2" with plasmid DNA) differed fundamentally from the manufacturing process used for the products authorized by Swissmedic ("manufacturing process 1") and the general public only became aware of this at the end of 2023 (while Swissmedic had known since the end of 2020). The products administered from manufacturing process 2 show a scandalously high level of bacterial self-replicating DNA impurities (so-called "plasmids"), such that all products made according to manufacturing process 2 should be regarded as "never authorized" as a consequence. However, Swissmedic tolerated this additional massive risk factor without informing the public and without suspending the mRNA authorizations.

• Initial animal studies – a mandatory prerequisite for clinical phase 2 and 3 trials and a key safety element – had not been carried out by the manufacturers at all or not to a sufficient extent, but they already showed disquieting results, for example with regard to the accumulation of toxic lipid nanoparticles.

• The subsequent studies on humans, on the basis of which the "temporary" authorizations were granted at the end of 2020, had only run for two months (instead of the usual 12–24 months) and were then de facto discontinued by the manufacturers by disbanding the control groups and were largely stripped of their medium and long-term significance.

Despite this alarming initial situation from a safety perspective, within the meaning of Art. 1 and Art. 3 of the Therapeutic Products Act, and despite numerous other circumstances that increased the risk, the first authorization of the mRNA "vaccines" was well and truly rushed through by Swissmedic. The applications for authorization were "reviewed" and approved in just 63 calendar days (an ordinary procedure would take 330 days, a procedure for "temporary" authorization usually takes 140 days), whereby important, mandatory, milestones were simply omitted.

As a result, these "temporary" authorizations within the meaning of Art. 9a TPA mean in actual fact that the entire Swiss population participated without their knowledge in the riskiest and largest clinical experiment ever to be conducted in Switzerland (and, by extension, the whole world). And this experiment has not been terminated to date (regarding the experimental character N 843 ff.).

Perpetuation of illegal authorizations that breach the law and duties

Disregard for all additional indications of risk

Without adequately addressing this immense risk created by Swissmedic itself (through the "temporary" authorization) and without at the very least informing the public of all the risks, Swissmedic proceeded unperturbed in June 2021 to extend its authorizations to adolescents aged 12 and over. This occurred although, in addition to all the other facts up to mid-June 2021 which increased the risk and were therefore legally relevant, it was known

• that regulatory authorities such as Swissmedic were flying completely blind due to a lack of strict batch testing and thus a lack of sufficient quality controls,

• that the dose authorized for adolescents was two times (Comirnaty) or five times (Spikevax) higher than the recommended dose, meaning that Swissmedic accepted an additional and again completely unnecessary risk among adolescents, an age group that was at no time seriously at risk during the pandemic year 2020 – i.e. just from COVID-19 without having been "vaccinated",

• that according to Pfizer's Post Marketing Pharmacovigilance Report, a total of 42,086 side effects and over 1,200 deaths had been reported for Comirnaty alone by February 2021 – i.e. within two and a half months, which should have led to the immediate termination of the trial,

• that according to this damning Pfizer report, as many as 13% of breastfed infants were affected by side effects and even Pfizer had identified a negative impact on male fertility as a potential risk,

• that, according to global adverse event reports, the alarm threshold of 50 deaths had already been exceeded by a factor of 150 by June 2021,

• that the COVID-19 "vaccines" had already proven in May 2021 to be significantly more dangerous than the flu, swine flu and measles vaccines– that were commonly administered up to that point – in view of the large numbers of adverse event reports.

Even these scandalous alarm bells did not prompt Swissmedic to seriously question the wrong path it had taken. Swissmedic neither limited the number of authorizations nor informed the public about the risks identified. Swissmedic did not even feel compelled to improve its own purely passive pharmacovigilance by recording the side effects identified in Switzerland. Instead, at the end of 2021, Swissmedic took the step of extending the authorizations to a third dose ("booster") and to children aged five and over, even though this youngest age group was not seriously at risk at any time during the pandemic year 2020 – i.e. from COVID-19 alone without having been "vaccinated" – and although by this point among other things (for information about many other risk factors) it was also known,

• that even representatives of the pharmaceutical industry were openly describing mRNA injections as what they really are – a form of gene therapy,

• that the toxic spike protein produced in the body of the vaccinated person is present in the body for much longer and in a much higher concentration than originally stated by Swissmedic and the manufacturers, which can lead to a number of serious side effects (including death),

• that data had been falsified and risk signals concealed in the context of the Comirnaty authorization study (Pfizer/BioNTech) (N 397 ff.), which should have led to the immediate withdrawal of the study,

• that Pfizer/BioNTech had presented an alarming interim report (PSUR) at the end of August 2021, according to which 46 cases had ended fatally in the clinical trials and 5,069 cases (1.6%) had already ended fatally in the so-called "postmarketing phase", which under normal circumstances should have led to an immediate revocationof the marketing authorizations,

• that Pfizer had delivered 7 batches with a massively increased number of adverse event reports to Switzerland – an alarm bell that should have led Swissmedic to immediately warn the population and even to recall the batches, but this has not yet happened,

• that at least 60 deaths were recorded of children in Switzerland, the EU and the USA for Comirnaty and Spikevax alone (N 438 f.), which means that the absolute alarm threshold of 50 deaths was clearly exceeded in this target group alone, which is in no way at risk from SARS-CoV-2, which should have led to the immediate suspension of this authorization extension at least, if not the suspension of all mRNA authorizations,

• that more than 2,000 premature births and stillbirths following mRNA injections had already been reported in the USA and the EU alone,

• that a worrying trend was already evident in Switzerland in 2021, namely a conspicuous and persistent death rate in younger age groups a short time after "vaccination activity",

• that the mRNA "vaccines" (Comirnaty and Spikevax) had received 60 times as many reports of serious side effects and 20 times as many reports of deaths per million doses administered in comparison with the influenza vaccines by the end of 2021.

Instead of finally suspending the mRNA authorizations, carrying out an in-depth analysis of the decisions taken, telling the public the truth about the risks that can actually be identified and improving the reporting system for recording vaccination side effects in line with these risks, Swissmedic continued to maintain all "temporary" authorizations in 2022. This occurred although, in addition to all the existing facts with risk and legal relevance (for information on many other risk factors, see N 1311), it was known

• that mRNA products belong to the group of ATMP high-risk products because "they contain nucleic acid, regulate gene expression and, as 'biologically active material' (i.e. RNA), are treated in the same way as genetically modified organisms (GMOs)", which even Swissmedic recognized,

• that for this reason alone and also in accordance with Art. 12 para. 5 lit. c and lit. e of the Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Authorization of Medicinal Products and the Authorization of Medicinal Products in the Notification Procedure (Verordnung des Schweizerischen Heilmittelinstituts über die vereinfachte Zulassung von Arzneimitteln und die Zulassung von Arzneimitteln im Meldeverfahren; VAZV, SR 812.212.23), a temporary authorization under Art. 9a TPA was unlawful from the outset (see 530, N 916 ff., N 992 ff.),

• that almost four million adverse reactions to all COVID "vaccines" had already been reported worldwide (Switzerland, EU, USA) by May 2022 (N 538 ff.), with Comirnaty and Spikevax alone accounting for over 1.7 million reports, including 464,971 serious adverse reactions and 20,886 deaths (N 548 ff.), exceeding the alarm threshold of 50 deaths worldwide over 400 times at that time, and that these figures continued to rise,

• that an alarming interim report on Comirnaty had once again been published by Pfizer/BioNTech ("PSUR No. 3"), from which it emerged

1. that under 50-year-olds were excessively subject to side effects, i.e. a population group only minimally affected by COVID-19,

2. that guidance on the safe use of Comirnaty for pregnant women, breastfeeding

   mothers and other patient groups was still lacking,

3. that there had been massive differences in quality between the individual batches

   and that many dangerous batches had once again been delivered to Switzerland,

• that despite Swissmedic's statements that the mRNA "vaccines" had no effect on pregnancy, there were reports, without taking underreporting into account, of 2,135 stillbirths after vaccination with Comirnaty and 798 stillbirths after vaccination with Spikevax as well as 5,055 miscarriages after all COVID-19 "vaccines" by May 2022 in the EU and the USA alone, with the manufacturers still openly admitting in 2022 that, due to a lack of corresponding studies, "the safety profile of the vaccine in pregnant or breastfeeding women is not known",

• that there was a historic decline in live births amounting to 8.5% across the world and also across Switzerland in 2022, for which mRNA injections remain the only plausible cause after excluding all other hypotheses,

• that, according to a study on male fertility published in June 2022, sperm concentration 150 days after the second "vaccination" was still 15.9% below the initial value, which means that not only female fertility but also male fertility might be significantly negatively affected by the "vaccination",

• that an in-depth analysis of the FSO data by Professor Konstantin Beck revealed a conspicuous and persistent mortality rate in all age groups a short time after "vaccination activity",

• that based on the FSO data in Switzerland, there has been a significant increase in a wide variety of disease diagnoses, especially within age groups not threatened by COVID-19 in any way (damage to the nervous system: +29%; cancer diagnoses: +48%; pregnancy complications: +25%; pulmonary embolism, cardiac arrest, stroke and cerebral infarction in 0 to 14-year-olds: +125%) since the start of the "vaccination campaign",

• that, according to several autopsy results, the "vaccine" spike protein was proven to be the cause of death and that, contrary to Swissmedic's official statements, it is not only detectable in the human body for a short time, but for up to nine months,

• that the occurrence of myocarditis in connection with a COVID-19 mRNA injection, which can be fatal in the worst cases, is, according to a study from Basel that has now been peer-reviewed, much more frequent and up to 800 times more frequent than officially reported by the regulatory authorities (N 674 ff.),

• that with VAIDS , a serious side effect that has been suspected to exist for a long time and has been increasingly recognized since 2022 has become apparent, which constitutes damage to the immune system, which can lead not only to an increased onset of autoimmune diseases and cancer, but above all to an increased onset of infectious diseases – and, in particular, also to a greater susceptibility to COVID-19 infections ("Long COVID"),

• that by 1 March 2022, at least 128 peer-reviewed publications on heart problems, 216 peer-reviewed publications on life-threatening coagulation disorders (thromboses, etc.) and six peer-reviewed publications on possible deaths as a result of COVID vaccinations have been published.

With the "temporary" authorization of the mRNA "vaccines", Swissmedic therefore accepted an unprecedented and steadily increasing risk to public health. At best, this could only have been justified by the fact that it could have averted an unprecedented threat (from SARS-CoV-2) and in doing so outweighed the exceptionally high risk associated with the mRNA "vaccines". This is clearly not the case.

Absence of a "life-threatening or debilitating" disease

"COVID-19" is not and has never been a "life-threatening or debilitating" disease that threatens the public at large, this being the key prerequisite for the "temporary" authorization.

With an infection fatality ratio (IFR) of 0.15%–0.20%, COVID-19 was already discernibly no more dangerous than moderate influenza at the end of 2020; there was no historically conspicuous excess mortality in relation to the overall population and hospitals were never overcrowded.

• Even in 2021, when the vaccination was rolled out on a large scale, there was no historical excess mortality according to the official FSO methodology (N 774), the hospitals never reached over 80% capacity and "Delta" was a variant that corresponded to a normal mild case of influenza in terms of the danger it posed.

• In 2022, it was obvious that COVID-19 was not the "pandemic of the century", that despite the massive manipulation of the COVID "case numbers" in hospitals which was made public, the health care system was never overloaded, and that the IFR for "Omicron" was only 0.001–0.002%, i.e. at least 50 times lower than the IFR for normal influenza.

No benefits from ineffective to harmful mRNA injections

In view of the above, Swissmedic authorized a highly experimental and dangerous medicinal product to prevent a disease that poses no greater threat to the population as a whole than influenza does. The only remaining "lifeline" for Swissmedic would therefore be to prove that the target group comprising older and previously ill people, who were initially at somewhat higher risk, had at least been protected against SARS-CoV-2 in a reasonably effective manner. But this is also far from being the case. The "vaccination" clearly failed to achieve the "high" levels of effectiveness required by the end of 2020:

• The "vaccinations" should have protected against serious (fatal or debilitating) diseases. However, the authorization studies (still ongoing, but without the control group) primarily investigated whether the "vaccinations" protect against headaches, coughing, suffering a fever and other trivial side effects in combination with a positive PCR test result.

• Up to 100% of the reported figures on the effectiveness relate only to such minor side effects and are based on calculations that in no way reflect reality. Instead, one can assume that the effectiveness comes in at a low, single digit percentage, if at all.

• Not a single study has even come close to proving that it offers protection against serious illness. The few cases analyzed fall within the range of statistical chance.

• "Vaccinations", however, would have had to "immunize" for the long term, which was not an achievable goal given the "booster vaccinations" that were planned from the outset.

• The "vaccinations" undoubtedly offered no protection against the transmission of SARSCoV-2 either and were therefore simply unsuitable for "pandemic control".

In 2021 and 2022, this lack of effectiveness manifested itself in an obvious way:

• In February 2021, there were already signs that the mRNA injections were largely

ineffective because the most common side effects included the "vaccination" being ineffective and contracting the COVID disease itself.

• To date, no effective proof of effectiveness for immunization has been provided by the manufacturers, nor has protection against transmission been proven in any way.

• With regard to the "booster", a negative effect was observed early on, as the transmission time was not shortened but extended.

• There has also been an increased number of cases of illness and death worldwide, which correlates with the start of the "vaccination campaign" in 2021 (and not with the start of the "pandemic" in 2020), which clearly indicates that the mRNA injections were not effective.

Omission of the most elementary safety and effectiveness tests

To make matters worse, Swissmedic had not based its decision on the strictest legal requirements for the ordinary authorization of medicinal products, but had allegedly issued "temporary authorizations" in accordance with Art. 9a TPA. However, under the guise of an alleged "pandemic", Swissmedic had undermined even the minimum requirements of Art. 9a TPA. The "pandemic authorization" of the mRNA "vaccines" granted in the case at hand deviates from the ordinary authorization in all key safety aspects in a way that increases the risk, and even falls below the authorization hurdles of the simplified and temporary authorization.

Accordingly, the authorization of the mRNA "vaccines" was accompanied by a blatant omission of the most elementary safety and effectiveness tests, thus posing the greatest of possible risk to the health of the Swiss population.

Swissmedic blocked effective alternative treatments

Another complication is that Swissmedic has not yet authorized more effective and less harmful treatments that have been known about for a long time, such as treatment with Ivermectin or other suitable approaches for the treatment of COVID- 19. In doing so, Swissmedic has deliberately sidelined the authorization requirement of a lack of alternative treatment methods (see Art. 9a para. 1 lit. c TPA) and thus actively blocked demonstrably more effective protection against COVID-19 (than the mRNA "vaccinations").

Benefit-risk analysis – Clearly a negative profile

Any serious analysis carried out in accordance with the law and common practice to determine the net benefit of mRNA-based COVID-19 vaccines for the entire population would have had to take into account at the end of 2020 and in the following years the verifiable facts summarized above and presented in detail in the evidence report. Such an analysis would obviously have shown that Swissmedic had authorized a medicinal product on the Swiss market with a devastatingly negative benefit-risk profile (see also Benefit- risk analysis: N 807 ff.; ER N 1835 ff.):19 Swissmedic's plan to authorize the mRNA "vaccines" for all adults in Switzerland from December 2020 must be seen as an experimental project posing a significant, unprecedented risk. At the same time, it was clear from the outset that the mRNA "vaccines" were not effective – a fact that has become increasingly evident over time. An unprecedented risk, which has since already demonstrated its impact in the form of a large number of serious side effects, was and is therefore not offset by any proven benefit. This consideration alone should have long since led to the compelling conclusion that the mRNA "vaccines" should never have been authorized and that the authorizations that were nevertheless granted represent a massive breach of the law and of due diligence on the part of Swissmedic.

New risks created by Swissmedic: maximum

The residual risk from "COVID-19" that may have still existed at the end of 2020 was perfectly manageable by conventional means among the general population up to the age of 65 and could have been safely managed without new active substances based on mRNA. In view of this low initial risk, Swissmedic should have applied a very restrictive risk tolerance to new medicinal products in order to fulfill the legal requirements of Art. 1, Art. 3 and Art. 7 TPA. Swissmedic should have rejected medicinal products with increased risk potential from the outset in order to avoid jeopardizing public health with new risks.

However, by authorizing mRNA-based COVID-19 vaccines, Swissmedic actually created new risks that were far greater and far more uncontrollable than COVID-19 itself (see Benefit-risk analysis: N 807 ff.; ER N 1835 ff.).

Flawed modeling study: "14.4 million deaths prevented"

Official bodies and numerous media outlets opposed the statements mentioned above on the fatal benefit-risk ratio of COVID-19 "vaccinations" by publishing a "modelling study" in September 2022. This caused a worldwide sensation because it allegedly provided proof that the COVID "vaccines" had prevented 14.4 million deaths during the "pandemic". An analysis of this study can be found in the evidence report which shows that it was based on false and manipulated data and was written by authors harboring obvious conflicts of interest. This study, which is based on model calculations that can be manipulated almost at will, is not suitable as evidence that meets legal standards and proves the alleged positive benefit of COVID-19 vaccinations. Instead, it is in stark contradiction to all the risks that had long since materialized by the end of 2022, based on real figures, and the continuing lack of genuine proof of effectiveness.

Continuing despite an obviously negative benefit-risk ratio

However, instead of finally carrying out a comprehensive benefit-risk analysis after two years of illegal "temporary" "pandemic authorizations" and immediately revoking the authorizations granted, or at least allowing them to expire, those responsible at Swissmedic took the completely opposite decision at the end of 2022. First, they tacitly extended the illegal authorizations in practice and, from 2023, continued with the new, still experimental mRNA therapy/prophylaxis in the sole interest of the manufacturers as a new platform for widespread use by means of supposedly "ordinary" authorizations. However, the requirements for the renewal of these "temporary" authorizations, and indeed for the granting of supposedly "ordinary" (Art. 9 and Art. 11 TPA) authorizations, were not even remotely met, which meant that those acting on behalf of Swissmedic were in much more serious breach of their duty of care under Art. 3 TPA and Art. 7 TPA than before.

All authorization orders or breaches of duty from the end of 2022 are to be seen as an independent, new offense with an independent, new decision to commit an offense. In terms of criminal law, these new offenses are particularly relevant because all the facts relating to the assessment of effectiveness and safety, both in qualitative and quantitative terms, were much clearer at the end of 2022 than at the end of 2020. By the end of 2022 at the latest, Swissmedic should have recognized that the manufacturers of these mRNA-based substances would never again be able to provide the legally required evidence regarding controllability of production, effectiveness and safety (objective impossibility.

No product monitoring proportionate to the risks

From the beginning until the present day, Swissmedic has also failed to take any adequate risk reduction measures to minimize the risk to the population as a whole posed by these mRNA "vaccines", which are authorized in contravention of the law and of recognized rules of good manufacturing practice. In particular, Swissmedic failed to ensure rigorous product monitoring:

• Despite the negative experiences with Pandemrix in 2009/2010, Swissmedic made do with a completely passive reporting system for market surveillance, which can in no way be considered to cover the risks adequately and is clearly insufficient for such a new and high-risk medicinal product that is still in the human trial stage (clinical phase III). Instead, the mRNA "vaccines" should have been subjected to active monitoring (pharmacovigilance) from the outset, as if under study conditions.

That would have been reasonable.

• However, Swissmedic did not even enforce the passive reporting system in a legally adequate way; in Switzerland, only about 10% of all side effects have been reported at all. This massive underreporting makes it impossible for Swissmedic and the public to identify the full extent of the devastating consequences.

• At the end of 2020 and the beginning of 2021, Swissmedic approved the almost complete discontinuation of the authorization studies, thereby relinquishing the central monitoring tool for examining effectiveness and safety without needing to do so.

• It is likely that Swissmedic also failed to ensure rigorous batch testing from the outset, which did not ensure in any way that the quality of the experimental mRNA medicinal products was examined independently of the manufacturers.

Misleading information not proportionate to the risks

Swissmedic failed in particular to take the reasonable and completely necessary risk reduction measure of providing the public with valid information and instead disseminated misleading or completely false information via prominent channels:

• Swissmedic informed the Swiss population about each authorization by means of media releases, which contained a whole range of misleading pieces of information. At the end of 2020, for example, Swissmedic announced that the authorisation of Comirnaty had been granted following a "ordinary" procedure, which is a blatant lie that many people still believe to this day. Swissmedic also spread the idea that the vaccines had a high level of effectiveness, which had never been proven, and concealed the fact that many questions about quality, effectiveness and safety remained completely unresolved. The claim made at the end of 2021 is particularly reprehensible, namely that Comirnaty had shown "high clinical effectiveness in younger children", even though the clinical trials had shown only minimal therapeutic benefit for trivial side effects (such as sore throats/headaches). Swissmedic thus exposed the section of the population that was at the least risk from COVID-19 to the risk of serious side effects and death in an unnecessary and completely misleading manner.

• To date, Swissmedic has failed to explicitly draw the public's attention to the fact that the "mRNA technology" in question must be considered a procedure that carries particular risks (gene therapy, GMO, ATMP, see N 6), and that there is no way of knowing or controlling not only the dosage of the injected mRNA ("pro-drug"; N 225 ff.; ER N 174ff.), but also the dosage, quality, production period and location of the spike proteins produced in the body ("active pharmaceutical ingredients"), which is why these highly experimental substances should have been tested only to the highest safety standards as part of an ordinary authorization procedure.

• In its information for healthcare professionals, Swisscare provided the doctors, who have a duty to explain the situation to their patients, and the patients themselves with all kinds of information that was obviously incorrect.

For example, they provided the advice that "no vaccine-related effects on female fertility, pregnancy, embryo-fetal development or the development of offspring have been identified", which is in stark contrast to study results and warnings from manufacturers and expert committees that were already available to Swissmedic at the end of 2020.

• Also missing – despite thousands of reports having been received – are any references to serious side effects such as "thromboembolic side effects", "herpes zoster (shingles)", "hearing loss/tinnitus", or "COVID-19 infections" ("vaccination failure"). This ongoing deception by means of untruthful documents within the meaning of Art. 317 SCC (for more detail see N 1427 ff.), not least supported by the other systematic acts of deception listed here, presumably led to flawed decisions to take the vaccine in millions of cases.

• Swissmedic also published "FAQ" directed at the public on its own website for a long period of time, which contained countless pieces of misleading information on mRNA preparations, although Swissmedic already had internal data at the end of 2020 which clearly indicated that its own "FAQ" were full of misleading information (N 1204 ff.; ER N 2240 ff.). In March 2023, for example, Swissmedic, as part of a response to the first question in the FAQ, claimed that the vaccines were "shown to be safe, effective and of high quality". Swissmedic even explicitly denied that there were any serious side effects: "so far there is no evidence of there being lasting negative consequences for individuals' health." This answer, like the entire official "FAQ", is symptomatic of the highest supervisory authority for drug safety in Switzerland pursuing a policy of permanent disinformation.

Swissmedic did not stop at issuing misleading media releases, misleading information for healthcare professionals and misleading information on its own website such as the "FAQ". Swissmedic also continuously disseminated misinformation about mRNA injections through numerous other channels (magazines, television, e-mail) – quite obviously with the aim of reassuring the Swiss population and ensuring a "willingness to be vaccinated".

In addition to all that has been said so far, the mere labelling of the mRNA-based preparations as COVID-19 "vaccines", per se, constitutes an independent act of deception of unprecedented proportions. According to Art. 2 lit. b of the Medicinal Products Licensing Ordinance (MPLO), medicinal products may only be authorised as vaccines within the meaning of this ordinance if they actually produce "active or passive immunity". With regard to COVID-19 vaccines, however, the opposite has been proven to be true. Empirical data from numerous countries shows a correlation between the frequency of COVID- 19 vaccination and susceptibility to COVID-19-related illnesses, hospitalizations and deaths. That is to say, the more COVID-19 vaccinations a person has, the greater their susceptibility to COVID-19 and the weaker their natural immune system.

Swissmedic has therefore not only caused enormous risks and dangers to the entire population, but it has also permanently kept the population in the dark about these very risks and dangers and given them a sense of false security. To this end, Swissmedic has also made use of official documents (authorization rulings, information for healthcare professionals and patient information) and its own official website.

Medical malpractice – lack of information, lack of reports

The effects of this consistent disinformation on Swissmedic's part largely continue to this day and touch on all the issues listed above that are relevant when making decisions:

1) Danger of SARS-CoV-2 (reality: less dangerous than stated);

2) Alternative treatment methods (reality: were available);

3) mRNA technology (reality: pharmacologically uncontrollable preparation, high-risk

technology GMO, ATMP);

4) Manufacturing and testing standards (reality: blatantly violated);

5) Protective effect of the mRNA preparations (reality: negative, not a "vaccination");

6) Risk profile (reality: historically high).

A large proportion of the population, who had only believed the official announcements, obviously only agreed to this mRNA vaccination on the basis of inadequate information regarding the 6 issues listed above that are relevant for decision-making. However, without proper information on all the facts relevant to the decision, consent can never be legally effective, which is why every mRNA vaccination carried out on the basis of inadequate information must be seen as bodily harm (for the requirements for valid consent, see N 1589 ff.).

But even the medical professionals who administered the vaccinations are by no means able to avoid taking responsibility by highlighting Swissmedic's misdemeanors. Instead, it is also necessary to examine the criminal liability of the doctors responsible for managing and vaccinating (in this case: the persons involved at the Insel Group), in particular if they did not provide any information or provided only completely inadequate information to the patients before administering (Art. 86 para. 1 lit. a TPA in conjunction with Art. 26 TPA) the mRNA "vaccines".

Based on the documents available to date, it is clear that, in the cases reported here, either no clarification was provided at all, or at best a five-minute explanation was documented, which is simply not adequate in view of the complexity of the mRNA "vaccines". Without informed consent, the "vaccination" was therefore carried out prematurely causing bodily harm or even death, which means that offenses under the Criminal Code must also be considered.

In addition, an examination into whether medical professionals have committed a violation of the prohibition on advertising medicinal products under therapeutic products law (Art. 87 para. 1 lit. b TPA) must also be carried out, if misleading information (such as that on the Insel Group website) has been and continues to be disseminated (N 1398). In view of the massive underreporting, there is also a strong suspicion that a large number of doctors have breached their due diligence with respect to their reporting obligations under therapeutic products law (Art. 87 para. 1 lit. c TPA; N 1364 ff.).

Swissmedic out of control and acting to the detriment of the state and the population

By the end of 2022, the persons acting on behalf of Swissmedic as well as the medical professionals involved had had more than sufficient time and opportunity to recognize the overwhelming risks and dangers of mRNA technology described in this report of a criminal offense and to respond adequately. They have all been under an obligation for a long time to put an immediate end to this devastating experiment and to do everything they possibly can to inform the population about this immediately and to protect them from further danger.

However, against their better judgement, they did not do so and continue to refrain from doing so, even though all the information made publicly available by Swissmedic (as the highest authority for the safety of medicinal products in Switzerland) is given maximum credibility by the law and even though lay people cannot identify Swissmedic's misconduct without making a significant effort and without the help of experts.

However, Swissmedic is not only violating Swiss law with its repeated and serious violations of the most fundamental duties of due diligence under therapeutic products law and standards for the protection of public health (illegal "pandemic authorizations" and their continuation, inadequate risk monitoring and misleading the public, which have been described in detail. In the absence of information about the special experimental nature of the substances in question and the risky mRNA technology per se, Swissmedic's actions and the administering of the mRNA injections are also in conflict with the provisions of mandatory international law (N 1211 ff.). Art. 7 of the UN Covenant on Civil and Political Rights (UN Covenant II; SR 0.103.2) stipulates that "no one shall be subjected without his free consent to medical or scientific experimentation" – not even "in time of public emergency which threatens the life of the nation and the existence of which is officially proclaimed" (Art. 4 para. 1 of the UN Covenant). Without the necessary information on all the risks and side effects relevant to making a decision, in particular on the experimental nature of the mRNA substances themselves, any injection of mRNA-based COVID-19 preparations based on Swissmedic's authorizations and their misinformation constitutes an act of "cruel, inhuman or degrading treatment or punishment" within the meaning of the UN Covenant and also within the meaning of Art. 10 para. 3 of the Federal Constitution (Cst.). There can never be any justification for violating this principle, which is mandatory under international and constitutional law, especially to the detriment of a large part of the population, as it lies at the heart of the human right to life.

All in all, the mRNA-based COVID-19 vaccines have proven to be of absolutely NO VALUE for Switzerland, both from an epidemiological-medical and economic point of view and also have an unacceptably high potential for risk and damage. What is particularly reprehensible is the fact that Swissmedic and the persons involved still do not want to rectify their misconduct even after more than 3 years, i.e.

[i.] that they have converted the authorizations originally granted unlawfully for a limited period of two years into permanent or ordinary authorizations,

[ii.] that they have not revoked any of the authorizations granted, and

[iii.] that they have still not adequately informed the public about the danger this has created.

In essence, this constitutes a total failure of the "Swissmedic safety system" – the highest authority responsible for the safety of medicinal products, which has virtually taken on a life of its own and is acting outside its legal mandate. The actual purpose of the Therapeutic Products Act, to protect the public from ineffective and harmful medicinal products, has been completely disregarded by Swissmedic and has been turned upside down. This specialized authority is unscrupulously deceiving all politicians, the media and the public about the concrete risk factors of mRNA technology that are well known, even though Swissmedic is well aware that the whole of Switzerland has blind faith in it and uncritically accepts Swissmedic's statements as the primary basis for any benefit-risk assessment in connection with the so-called COVID-19 "vaccinations".

Without effective intervention across all authoritative channels, including parliamentary oversight from the Swiss Confederation (Art. 169 ff. Cst.), the suffering of the Swiss population, which is already immeasurable in too many individual cases, will be unnecessarily exacerbated. There is also the threat that those affected, the economy, health insurance companies and public budgets will suffer significant additional economic loses. However, there is also the threat of lasting, profound damage to the credibility of all the authorities involved here, including the entire Swiss Confederation.

Finally, in light of the renewed proclamation of an international health emergency (WHO: "Public Health Emergency of International Concern", Art. 12 International Health Regulations; Federal Council: "Special situation", Art. 6 EpidA), the threat looms that the dangerous mRNA preparations with negative effectiveness will once again be purchased and administered millions of times despite their unsuitability, which has been proven in a way that is more than transparent, and despite the established prevailing risks which this experimental technology poses of creating new pathogens and, once again, without carrying out the randomized, controlled long-term trials that are absolutely essential and without manipulating those trials.

For all these reasons, urgent coercive measures (searches of the Swissmedic premises, seizure of the mRNA "vaccines") must be taken immediately to protect against these illegal and high-risk mRNA injections. In addition, active measures must be taken at long last to ensure that the Swiss population, which continues to be misled, is informed about this multitude of problems in a complete and transparent manner.

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