EMA Destroys Foundation for Vaxx Mandates

Courtesy of a few honourable MEPs, the EMA was forced to concede that Covid vaxx mandates lack any regulatory foundation

Read up on the EMA’s admission of, yes, fraudulent negligence on part of the European ‘regulator’ tasked with oversight (ahem) over medicinal products.

For a German news item by Peter Mayer over at TKP, click here.

For a copy of the letter, signed by Emer Cooke, Head of the EMA, click here.

Shout-out to MEPs Marcel de Graaff, Gilbert Collard, Francesca Donato, Joachim Kuhs, Mislav Kolakušić, Virginie Joron, Ivan Vilibor Sinčić, and Bernhard Zimniok: thank you for dragging these shenanigans out into the open.

I’m reproducing the letters in part, with emphases added, but you’re of course advised to read the entire letters. For improved readability, I’ve omitted the references.

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From the MEPs’ Open Letter to the EMA, 4 Oct. 2023

Here is the open letter by that intrepid group of MEPs, courtesy of Marcel de Graaff:

We therefore request the direct suspension of the marketing authorizations of the following COVID-19 vaccines:

• Conditional Marketing Authorisation Pfizer (Comirnaty) dated 21 Dec. 2020.

• Conditional Marketing Authorisation Moderna (Spikevax) dated 6 Jan. 2021.

• Renewal of Marketing Authorisation Pfizer (Comirnaty-tozinameran) dated 31 Aug. 2023.

• Renewal Marketing Authorisation Moderna (Spikevax-elasomeran) dated 15 Sept. 2023…

These therapeutic indications do not align with the fact that these vaccines are being promoted by pharmaceutical companies, politicians, and health professionals due to their potential for transmission control.

As a medicines agency, you are supposed to be well-versed in the intended medical uses of these vaccines. This essentially means that these medicines, including vaccines, should only be administered to individuals who seek personal protection, and they are not authorized for the purpose of reducing transmission or infection rates (transmission control).

I’ll interrupt the flow here as these MEPs are awesome, for they used the EMA/EU’s own rules (which they cite constantly, incl. the smallest minutiae) to show that the marketing authorisation stands in contradiction to the facts.

They don’t stop there, though, for they also buttress their demands for withdrawal of the marketing authorisation by pointing to other, equally ‘obscure’ regulations pertaining to GMOs:

The main rules for allowing genetically modified organisms (GMOs) in the environment can be found in Articles 6 to 11 of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC…the rules for this are enormously strict…

However, an unusual occurrence transpired on July 15, 2020. In response to the COVID-19 pandemic, a new Regulation was hastily introduced and became effective on July 18, 2020 (refer to Article 5). The key provisions of significance are found in Articles 2(1) together with (2) and 4(1) of Regulation 2020/1043/EU. This regulation pertains to the conduct of clinical trials involving medicinal products designed for human use that contain or consist of genetically modified organisms and are intended for the treatment or prevention of coronavirus disease (COVID-19), as well as the supply of such medicinal products…

This Regulation allowed for a temporary derogation from the very strict rules of Directive 2001/18/EC.

Of particular significance are Articles 6 and 9 of the Directive. These articles pertain to the authorization procedure and public consultation and information…

The main rule is however that a GMO can only receive authorization in the European Union once a technical dossier, which includes seven specified documents, has been submitted, along with an environmental risk assessment. [gotcha]

Recently, a report titled ‘Resilient Biotechnology Policy: Lessons from the COVID-19 Crisis and Opportunities for Enhancing Resilience in Biotechnology Policy’ was issued by the Committee on Genetic Modification (COGEM) on October 11, 2022, and made public on December 16, 2022.

Chapter 3 of this report shows that Regulation 2020/1043/EU is void because it is not based on the correct legal basis. Articles 114 or 168(4)(c) of the Treaty on the Functioning of the European Union (TFEU) cannot be invoked in this case. This means that the rules of Directive 2001/18/EC continued to apply in full and that a technical dossier and an environmental report should therefore have been submitted. Having failed to do so, all the permits issued were thus unlawfully granted to the pharmaceutical companies.

Quite a bit technocratic mumbojumbo, eh? Please allow me to translate from Eurospeak to something approximating plain English:

• You hastily changed the rules concerning the release of GMOs into the environment in 2020 to facilitate the fast-tracked EUA of the Covid injectables.

• Manufacturers did not follow the rules for this, and you did not demand adherence to said rules about the release of GMOs.

• Hence, all permits issued ‘were thus unlawfully granted’.

Put differently: time to lawyer up, fellers, and face the music for all the subsequently, if equally unlawfully imposed, crap, incl. so-called ‘Covid Passports’, travel restrictions, limitations on domestic affairs, such as ‘social distancing’, access restrictions, and all other mandates deriving from the EUA granted unlawfully to these pharmaceutical products.

Quite a bit, eh? Let’s dissect what the EMA answered.

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EMA Concedes that Which Can No Longer Be Denied

Thank you for your letter of 4 October 2023 in which you call for the suspension of the marketing authorisations of the mRNA COVID-19 vaccines Comirnaty and Spikevax…

You state that based on the authorised indications, the vaccines ‘should only be administered to individuals who seek personal protection, and they are not authorised for the purpose of reducing transmission or infection rates (transmission control)’. You also state that the authorised indication does not align with uses promoted by ‘pharmaceutical companies, politicians, and health professionals’.

You are indeed correct to point out that COVID-19 vaccines have not been authorised for preventing transmission from one person to another. The indications are for protecting the vaccinated individuals only.

The product information for COVID-19 vaccines clearly states that the vaccines are for active immunisation to prevent COVID-19. In addition, EMA’s assessment reports on the authorisation of the vaccines note the lack of data on transmissibility.

There goes any legal or regulatory foundation for Covid Passports and, generally, any mandate (restrictions) deriving from the faulty—fraudulent—notion that having gotten ‘vaccinated’ somehow prevents infection or transmission.

EMA: No Emergency Needed for Continuation of EUAs

As I’ve explained some 1.5 years ago, the EU has since moved on from requiring an ‘emergency’ for the issuance of an ‘emergency use authorisation’ (in Eurospeak that would be a ‘conditional marketing authorisation’):

EU Institutionalises Covid Passports: No More Emergency = Continued Emergency Measures

Hence, the below ‘answer’ does not surprise me even a bit (although I’m sick of these technocratic bureaucrats imposing their ill-informed crap on all of us):

You note that data from clinical trials are not available for adapted vaccines targeting Omicron XBB.1.5 subvariant. Given this and the fact that the international public health emergency is over, you question the need for authorising the adapted vaccines at this time.

We would like to stress that the authorisation of adapted COVID-19 vaccines is not contingent on the continuation of the public health emergency. The authorised indications do not restrict the use of the vaccines to an emergency. [see what I mean?]

Furthermore, data from clinical trials were not a scientific requirement for the Omicron XBB.1.5 adapted vaccines because of the information derived from the originally authorised and earlier adapted vaccines.

Here, we’re almost coming full circle in terms of circular reasoning (sic): re-read the above first answer, which holds that ‘COVID-19 vaccines have not been authorised for preventing transmission’ and and that ‘EMA’s assessment reports note the lack of data on transmissibility’.

So, to follow the EMA’s ‘logic’ on this one, as ‘data from clinical trials were not a scientific requirement’ for the authorisation of the ‘the Omicron XBB.1.5 adapted vaccines because of the information derived from the originally authorised and earlier adapted vaccines’.

Rendered into plain English, the EMA waived certain data requirements for the original EUA to justify the rushing through of the subsequently ‘authorised’ injectables based on the former. Classic circular reasoning, if you’d like to call it that.

One more quote before we move to the GMO release issue:

Where the ending of the public health emergency may be relevant is in the vaccination strategies of EU Member States and the advice given to the general population. In this regard, the product information for COVID-19 vaccines state that the use of the vaccines ‘should be in accordance with official recommendations’.

Translation: we don’t care what your member-state regulators and ‘public health officials’ do, for this is none of our business.

What About GMO Release, Then?

I understand you have concerns about Regulation (EU) No 2020/1043/EU (“the Regulation”) which, as stated in its Article 2 of the Regulation, allows for the conduct of some clinical trials with products containing GMOs without a prior environmental risk assessment [what a patronising crap]…

It is important to first clarify that mRNA vaccines are not considered genetically modified organisms [huhum, quite a claim, and the EMA merely links to the pertinent, rushed-through regulation from 2020, and we’ll have to interrupt the flow here, again, to check this out]

Art. 1 of this regulation from 2020 read as follows:

(4) ‘medicinal product’ means medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC;

(5) ‘genetically modified organism’ or ‘GMO’ means genetically modified organism as defined in point (2) of Article 2 of Directive 2001/18/EC

Let’s check out said Directive 2001/18/EC, then, I suppose, whose Title 1, Art. 1, reads as follows:

Medicinal product :

(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

Did you catch the sleight-of-hand here? In the letter, the Head of the EMA says the modRNA injectables don’t prevent transmission, hence they don’t quite fall into the definition as per Directive 2001/18/EC.

Curiously enough, the Directive also notes registration of all ingredients in any product in the pharmacopeia, explicitly relating to excipients ALC-0315 and ALC-0159, which are not contained in the relevant C&L Registry (see in-depth reporting here).

Back to the EMA letter now:

It is our understanding that the Regulation was intended for other vaccines, such as vaccines that ‘contain attenuated viruses or live vectors, which may fall within the definition of a GMO.’

Let that sink in: the EMA ‘understands’ the GMO regulation to pertain to non-modRNA products, such as the injectables by J&J, AstraZeneca, or Novavax. I don’t understand how they can write that kind of BS (apologies to cows), esp. as it is in the friggin’ name of the thing (modified RNA).

That said, we can provide you with information on the status of the environmental risk assessments for Comirnaty and Spikevax.

At the time of the initial authorisations of Comirnaty and Spikevax, the CHMP noted in its published assessment reports that, due to their nature, ‘vaccines and lipids are unlikely to result in a significant risk to the environment’. The Committee further noted that it was acceptable for environmental risk assessment studies not to be provided in the applications for marketing authorisation. You can find more information in the published assessment reports on EMA’s website as well as the CHMP Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use.

On the basis of the Regulation, you also imply that with the end of the public health emergency, companies should now provide prior environmental risk assessments for adapted vaccines.

Having clarified that the vaccines are not GMOs and the Regulation does not therefore apply, we would also like to clarify that adapted vaccines are not new vaccines with marketing authorisations separate from those of the originally authorised vaccines. Any theoretical environmental risks they may pose are considered to be the same as those of the originally authorised vaccines.

On a separate note, national authorities approve clinical trials in the EU and would therefore be the authorities to receive any environmental risk assessments required before the start of a clinical trial.

See how technocrats shift responsibility? National authorities follow the EMA’s regulations and guidelines while the former can always point to the latter’s authority on any such matters.

Also, what, exactly, are modRNA products according to your logic?

As an aside, ‘even’ after the regulations were changed in mid-June 2020, manufacturers considered modRNA products ‘gene therapy’.

On Corrupted ‘Good Manufacturing Practices’

You refer to emails released by hackers, some referring to the quality of Comirnaty. It is important to note that during the evaluation of medicines, issues arise which need to be resolved before EMA can recommend an authorisation. A collection of selected emails cannot provide an accurate or full picture of what the issues were or how they were resolved. In this case, the issue concerned mRNA integrity (i.e. whether mRNA in the vaccine remained intact as expected).

While some truncated mRNA pieces were found in the vaccine, the CHMP concluded in 2020 that ‘proposed specifications for RNA integrity and 5’-Cap are considered to be scientifically justified and acceptable. Nevertheless, additional data to complete the characterisation of the active substance and finished product, and considering clinical experience, are considered important to confirm the adequacy of these specifications, and these data should be provided post-approval as specific obligations to the MA [marketing authorisation]’.

The company has since provided all the required information, and the specific obligations have been fulfilled. The CHMP has accepted the latest specifications proposed by the company.

See, problem solved. Sure, ‘some truncated mRNA were found in the vaccine’ (how re-assuring, eh?) as early (!) as 2020, but since the subsequently authorised ‘updated’ injectables derived their EUA from the earlier EUA (about which the CHMP stated were ‘scientifically justified and acceptable’), no further data has apparently been required. Nothing to see here, folks, move on.

On the Legal Status, Directives, and Regulations

The MEPs raise a ton of concerns, and here’s the EMA’s answer:

We read these concerns as being related to the Regulations and Directives themselves. While EMA is bound by them, we are not in a position to comment on the appropriateness of Regulations or Directives adopted by Parliament and the Council or on their compatibility with the Treaty.

I call this the Adolf Eichmann in Jerusalem defence, for EMA effectively says that ‘we’re just following orders here, and we cannot say if what we’re doing is “right” or “wrong” as this is not for us to decide’, let alone reflect upon.

Let’s not mince words here: if that standard applied at the Nuremberg Trials, all the accused Nazis would have gone free. Note, further, that literally all the post-WW2 international (human) rights have as their foundation that ‘I was just following orders’ defence is considered ‘not (nearly) enough’.

Yet, there’s more BS:

It is true that the protection wanes over time as the virus itself evolves, and this is one of the reasons why adapted vaccines have been authorised [which was done, mind you, without requiring any new data as the original application was once considered ‘scientifically justified and acceptable’]. It is important to note that with SARS-CoV-2, people may be exposed to the virus several times and repeated exposure may increase the chance of infection even in vaccinated people.

COVID-19 vaccines also provide protection against severe disease, including hospitalisation. This is particularly important for vulnerable people who are at increased risk. [note that no source or data is provided here, i.e., it’s nothing but an assertion without evidence]

Concluding Remarks by Emer Cooke, Head of the EMA

Finally, we take note of your call for immediate action to suspend the marketing authorisations of Comirnaty and Spikevax, including the authorisations of the adapted vaccines targeting the Omicron XBB.1.5 subvariant.

EMA’s CHMP can only recommend suspensions of the marketing authorisations if the evidence shows that the risks outweigh the benefits [no evidence is provided]. The evidence continues to show that the vaccines provide protection [again, no evidence provided], which is particularly important for vulnerable people. Removing these vaccines as an option for EU Member States and for healthcare professionals without due regard to available data would therefore be a great disservice to the EU and to public health. [oh, look, would that mean that member-states of the EU/EEC could remove the EUA? I suppose that would make for a ‘fun’ kind of ‘nullification crisis’…]

Bottom Lines

Apologies for the overly long and wonk-ish posting, but this is important on the following grounds:

• Circular reasoning has become the MO of ‘public health officialdom’ in 2020.

• Evidence-based medicine as practices by public health officialdom is, well, a misnomer.

• There’s no regulatory or other foundation for any modRNA injection-derived limitations on human freedom and agency.

• The EMA knew about manufacturing problems as early as 2020, but they never followed-up on it.

• The EMA Head also invoked the Eichmann defence, which, let’s remember this, didn’t serve him too well (but I suppose it’s a tacit admission of increasing fear levels among public health officialdom).

• What the EMA writes about ‘good manufacturing practices’ is something a corporate compliance officer should look at—and laugh hysterically. I suppose if business operated like these quasi-public (ahem) institutions, they’d be out of business before too long.

Time to lawyer up and file class action suits and get outraged at those politicos, ‘experts™’, and their willing executioners in legacy media.

#we demand justice.