The Swiss approval and supervisory authority for medical and pharmaceutical products, Swissmedic, does not come from the negative headlines. After a criminal complaint that received worldwide attention due to alleged illegal actions in the course of the corona pandemic, it is now claimed that the new Moderna booster vaccines were approved for an unlimited period without a legal basis. The type of authorization granted would be entirely unknown in Swiss law.
With the “unlimited approval” communicated on March 8, Swissmedic is said to have issued a form of approval that is not known at all under Swiss law on medicinal products. At the same time, the requirements for alternative forms of approval (particularly for regular market approval) were not met. The law firm Kruse Law published a press release on this, which we reproduce below:
Zurich, March 9, 2023 – According to a press release dated March 8, 2023, Swissmedic has given Moderna’s bivalent Covid-19 Original / Omicron BA.4-5 booster (“Spikevax Original / Omicron BA.4-5”) “indefinitely ” authorized. This step comes after the 2-year period of temporary approval for the parent compound (Spikevax/Moderna) expired on January 12, 2023. With the “unlimited approval” communicated yesterday, Swissmedic is now choosing a form of approval that is not known at all under Swiss law on medicinal products. At the same time, the requirements for alternative forms of approval (in particular for regular market approval) are not met. On what legal basis was this “unlimited approval” granted? Swissmedic has yet to answer this question.
“Permanent admission” outside the law
A so-called “unlimited approval”, as communicated by Swissmedic in this case, is not provided for either at the level of the law or of the ordinance. There is simply no legal basis for such a type of approval. If Swissmedic meant ordinary authorization (Art. 9, 10, 11 and 16 HMG) with the “unlimited” authorization granted yesterday, this would have to be classified as illegal from the outset: the necessary extensive authorization documents, in particular long-term studies, could be submitted within this short period of time ( impossible to submit since the application for authorization for the BA.4-5 «Booster» was received on November 18, 2022)2. It can therefore only be assumed that Swissmedic continued to issue the present “unlimited authorisation” on the basis of Art. 9a HMG (so-called “limited authorisation) – as was the case with the previous versions of Spikevax (including the first bivalent vaccine «Spikevax Bivalent Original / Omicron») was the case.
The following should be noted in this regard: Half of the “Spikevax Original / Omicron BA.4-5” medicinal product (which, according to Swissmedic, should be used as a “refresher vaccination/booster”) consists of the active substance of Spikevax, the active substance for primary immunization. For this reason, the approval of the “booster” based on this is to be regarded formally as an extension of the approval of the basic substance. However, because the law does not allow the limitation to be lifted within the framework of so-called “limited approval” according to Art. 9a TPA, the granting of “unlimited” approval within the framework of Art. 9a TPA represents an obvious violation of the law. An “unlimited” “limited approval”. » does not exist and is a contradiction in terms.
Incidentally, there has long been no legal basis for any type of special regulations related to threats (actual “emergency admissions”) – whether they are “limited” or “unlimited”: there is simply no illness that would be life-threatening or disabling for the entire population. For this reason alone, the temporary approvals for all Covid 19 “vaccines” should have been revoked long ago.
Risks of Covid-19 “vaccinations” are ignored
With yesterday’s press release, Swissmedic continues to keep the population in the dark about the true extent of the risks of this new type of drug: Swissmedic writes that the “safety profile of the adapted vaccine […] comparable to that of the original mRNA vaccines”. This is in no way reassuring, but of great concern, as the original COVID “vaccines” have resulted in an unprecedented number of (serious) side effect reports. According to official figures from the American side effects database VAERS, for example, the COVID “vaccines” cause 58 times more deaths and 31 times more hospitalizations than flu vaccines. This alone would be reason enough to immediately suspend all temporary COVID approvals.
Instead, Swissmedic’s approvals, which are only granted for a limited period of time, are being continuously renewed. At the same time, the population continues to be misled about the true extent of the risks: Swissmedic, for example, still writes on its website (“FAQ on the Covid-19 vaccines”) in response to the question: “Are the Covid-19 vaccines safe?”:
“Only vaccines that have been proven to be safe, effective and of high quality are approved in Switzerland. So far there is no evidence of lasting negative consequences for health.”
Such misinformation has no place on the website of a licensing authority, which must “protect the public from deception” (Art. 1 Para. 2 HMG).
Endangerment of the Swiss population
The mandatory legal requirements for the approval of Spikevax/Moderna are therefore still not met. As of today, this medicinal product should therefore not be placed on the market by means of so-called “limited approval” (Art. 9a TPA) or by means of “regular approval” (Art. 9 TPA). With Swissmedic now allowing the approval of Moderna’s bivalent Covid-19 Original / Omicron BA.4-5 “Booster” “indefinitely”, the supreme supervisory and approval authority for medicinal products is operating outside of the Therapeutic Products Act. It also prevents people in Switzerland from being able to take the true extent of the drug risks into account when making their personal vaccination decisions.
With this approach, Swissmedic continues to endanger the health of the Swiss population instead of protecting it. These developments confirm the need to vigorously pursue our criminal complaint against Swissmedic (see: www.impf-anzeige.ch) filed on 14 July 2022 on behalf of 6 vaccination victims and 37 other complainants and to update our evidence. More information on this process will follow in due course.