Die EMA war angefragt worden, ob und wie sie die Covid-„Impfung“ in Wirklichkeit zugelassen habe.

Ich war mitten im Vortrag (Video) und hups, das Video war weg, höchstvermutlich zur Minute, da ich es mir reinzog es wegzensiert musste worden sein. Nämlich alles Andere darüber und darunter war noch da, und meine Finger waren fern von Tastschirm.

Weiß Wunder!

Was die EMA den Behörden (angeblich? will sich die EMA reinwaschen?) an Auskünften über die Covid“impf“stoffe gegeben hatte, das war nicht das, was die Regierungen den Völkern präsentierten. Gemäß des aktuellen Antwortschreiben der EMA hätten die Regierungen auf keinen Fall zu Impfung drängen dürfen, gemäß EMA-Schreiben wussten die Regierungen recht genau, was die „Impfung“ ist und was sie nicht ist, haben die Völker somit kalt hinter das Licht geführt, damit Milliarden vergiftet, Millionen umgebracht. Millionen werden folgen. Unfruchtbarkeit unter den Gespritzten grassiert.

Sicher in Erinnerung habe ich Zweierlei:

A Die EMA hatte (habe? nochmal: will sie sich reinwaschen?) klipp und klar gesagt, mittels sich „impfen“ lassen erwirke man keinen Schutz für seine Umgebung, nicht das geimpfte Kind für das ungeimpfte Grosi, nicht das geimpfte Grosi für das Kind.

Was doch trompetet wurde: „Du gefährdest dein Kind, deinen Nachbarn, deine Mutter, wenn du nicht „impfst“; du bist es deinen Nächsten schuldig.“

B Es sei Individual“impfung“, das heißt, ein jeder einzelne Impfling hätte von jedem einzelnen Arzt über die zu erwartenden Wirkungen des Stoffes restlos aufgeklärt werden müssen.

Die Ärzte konnten das nicht, denn nirgends stand von offizieller Seite geschrieben, was der Saft im Körper anstellen wird.

Arzt aber, der das nicht kann, darf nicht spritzen. Gehts denn noch? Weil Politik und Medien „impfen impfen“ schreien, entbindet das den Arzt nicht von seiner Informationspflicht. Millionen Ärzte haben etwas gespritzt, von dem sie nicht wussten, was es ist. Sie haben sich schweren Verbrechens schuldig gemacht.

Da waren noch andere brisante Punkte im Antwortschreiben der EMA. Ich erinnere leider vage nur, und, wie gesagt, ich muß dringlich annehmen, daß die Ansprache vom Netz genommen ist. Sie fand, so vermutete ich, vor einem Gremium des Europäischen „Rates“ statt.

Die Zensur wird nichts fruchten. Raus ist raus. Wir haben schnelle Leut, die sichern sich sowas sofort, und ich nehme wohl an, daß sie tausendmal gesichert ist und im Netz derer, welche der Wahrheit verpflichtet sind, sich verbreiten wird.

Die anderen Punkte, die ich vage in Erinnerung haben, die ergeben als Essenz:

Die EMA hatte (immer mit Fragezeichen: Heute Reinwaschversuch?) den Saft zwar freigegeben – ja wie was nun denn, wurde er doch von der EMA nicht als sowas als wie „verdächtige Brühe“ deklariert, als das die EMA sie heute ausgibt, sondern wurde freigegeben. Man kann nicht „ein bisschen freigeben“. Die EMA hatte freigegeben. Je länger ich darüber nachdenke, desto mehr neige ich zur Meinung, die EMA wolle sich heute, da die Wahrheit über den Saft das Faß der Geheimhaltung überläuft, reinwaschen, und sie gesteht „freimütig“ ein die Gefahren der Plörre.
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Nun aber wird die Rede der EMA, im Brief in Worte gefasst, öffentlich. Na ja, MAN nimmt das Vid der Rede vom Netz. Was heisst schon „vom Netz“. Blöd für SIE, daß auch für SIE gilt: Was raus ist, das ist raus; es wird nicht nur von den drei großen Tieren (Mega-Internet-Gedächtnisse, ein jedes ein AKW zu Betrieb benötigend) gespeichert, sondern auch vom Papi in Hinterfindlingen, vom redlichen Journalisten in Berlin Tiergarten, von der vifen Trutherin in ihrem Gartenhaus.

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Sollte ein Leser auf die Rede stoßen, dann bitte ich um Verlinkung.

Glückauf hat es geschafft. Danke!

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Detaillierter Bericht, auch von Glückauf gefunden, hier lang:

COVID-19 „Experten“: Nun werden sie auch von der EMA bloßgestellt

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Da isserja, der Vortrag!

https://twitter.com/i/status/1727425970259292659

Das Geschehen überschlägt sich. Heute „Zufallsbekanntschaft“ am Strand mit zwei smarten Ukrainern. Der Eine setzte zu einem Vortrage an über die Verrücktheit der aktuellen Waffenproduktion und über die von ihm erwartete Veränderung der Erde, hin zu Einigkeit in Vielfalt.

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Love.

Thom Ram, 24.11.11

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Nachträglein

Was die EMA geschrieben hat, ich meine, es ist als wie wenn Trost en, Zahnfee und Weiland im Dezember auftreten und sagen würden: „Wir haben immer vor der Impfung gewarnt.“

Nachnachträglein

Am Ende zerfleischen sie sich untereinander, eigenes Zerstörungs-Verursachertum abstreitend, sich gegenseitiger Schuldzuweisung befleißigend.

Nachnachnachträglein

Insofern könnte man wohl denken: zurücklehnen und Popkorn essen.

Nachnachnachnachträglein

Ich mag Popkorn nicht, bin damit gefeit von Natur aus für die Zurücklehnhaltung.

Leut, gut Leut, wir machen weiter.

Heiter.

Und wenn die Heiterkeit entflieht,

dann wissen wir, daß einer sieht.

Und wer ist das,

der Günter Grass?

Nö nö nö,

ICH bin es, der sehend wissend lebt und webt,

Du bist es, der sehend wissend lebt und webt.

Nachnachnachnachnachträglein.

Lasst uns unsere Webstühle hegen und pflegen.

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Hier der Brief der EMA, leider nicht formatiert.

Formatiert findest Du ihn hier:

COVID-19 “Experten”: Nun werden sie auch von der EMA bloßgestellt

Official addressDomenico Scarlattilaan 6●1083 HS Amsterdam●The NetherlandsAn agency of the European Union Address for visits and deliveriesRefer to http://www.ema.europa.eu/how-to-find-us Send us a questionGo towww.ema.europa.eu/contactTelephone +31 (0)88 7816000© European Medicines Agency,2023. Reproduction is authorised provided the source is acknowledged.Marcel de Graaff MEPEuropean ParliamentASP 06E24060, rue Wiertz / Wiertzstraat 60B-1047BrusselsBelgiumEmail: marcel.degraaff@europarl.europa.eu18 October 2023EMA/451828/2023European Medicines AgencyDearHonourable Members of ParliamentMarcel de Graaff, Gilbert Collard, Francesca Donato, Joachim Kuhs, Mislav Kolakušić, Virginie Joron, Ivan Vilibor Sinčić and Bernhard ZimniokThank you for your letter of 4 October 2023 in which you call for the suspension of the marketing authorisations of themRNA COVID-19 vaccines Comirnaty and Spikevax. The European Medicines Agency is committed to protecting public health by conductingthoroughscientific assessments of medicinalproductsfor the EU. We are equally dedicatedto ensuring that the public and their representatives in the European Parliament are informedof the reasons why their medicines are authorised and of the measureswetaketo monitor themonce they are available.We should also emphasise that EMAfocuses mainly onone aspectof EU health policy, namely the authorisation and monitoring of medicinesand vaccines. When ourscientific committeesissue recommendations,other bodies,such asthe European Commission, theEuropean Centre for Disease Prevention and Control (ECDC) andnational health and vaccination authorities can consider them as they developimmunisation policies to protect the public.Please findbelow direct responsesto the questions you raisein your letter.

1.The authorised indicationsYoustatethat 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 thatthe 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 individualsonly.The product informationfor COVID-19 vaccinesclearly states that the vaccines are for active immunisation to preventCOVID-19. In addition, EMA’sassessmentreportson the authorisation of the vaccines note the lack of data on transmissibility. EMA will continue to be transparent about the approved uses of COVID-19 vaccines and identify areas where we need to tacklemisconceptions.

2.Authorisation of vaccines targeting the Omicron XBB.1.5 subvariantYou 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 emergencyisover, you question the need forauthorisingthe adapted vaccinesat this time.We would like to stress that the authorisation of adapted COVID-19vaccines is not contingent on thecontinuation of thepublic health emergency. Theauthorised indications do not restrict the use of the vaccines to anemergency. Furthermore, data from clinical trialswerenot a scientific requirementfor the Omicron XBB.1.5adaptedvaccines because of the information derived from the originally authorised and earlier adapted vaccines. In its decisionsto recommend authorisationof vaccines targeting the Omicron XBB.1.5 subvariant, EMA’s human medicines committee(CHMP)considered all the available data on both the originally authorised vaccinesand earlieradapted ones, including data on safety, efficacy and immunogenicity (how well they trigger immune responses). In addition, the Committee assessed laboratory data on theresponsesof the adapted vaccinesagainst XBB.1.5 and related strains of SARS-CoV-2, the virus that causesCOVID-19.Please also note that for Spikevax XBB.1.5, the Committee assessed some clinical data from an ongoing study.Wheretheending of the public health emergency may be relevantis in the vaccination strategies of EU Member Statesand the advice given to the general population. In this regard, the product information for COVID-19 vaccines state that theuse of thevaccines‘should be in accordance with official recommendations’.

3.Environmental risk assessmentsfor genetically modified organisms (GMOs)I understand you have concerns about Regulation(EU) No2020/1043/EU(“the Regulation”)which, as stated initsArticle 2of the Regulation, allows for the conduct of some clinical trials with products containing GMOs without a prior environmental risk assessment.You also note that,according to Article 4, the Regulation shall‘apply as long as WHO has declared COVID-19 to be a pandemic or as long as an implementing act by which the Commission recognises a situation of public health emergency due to COVID-19’.It is important to first clarify that mRNA vaccines are notconsidered genetically modifiedorganisms. It is our understanding that the Regulation was intended for other vaccines, such asvaccines that ‘contain attenuated viruses or live vectors, which may fall within the definition of a GMO.’1That 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,dueto 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 1https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R1043as well as the CHMP Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use.2On 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 thevaccines are not GMOsand the Regulation does not therefore apply,we would also like to clarify thatadapted vaccines are not new vaccines with marketing authorisations separate from those of the originally authorised vaccines.Any theoretical environmental risksthey may poseare 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 authoritiesto receive any environmental risk assessments required before the start of a clinical trial.

4.Safety, efficacy and qualityof vaccinesSafetyIn response to your comments aboutthe safety of the vaccines,we would like to point out that EMA and national authorities continuously monitor data on reported side effects. It is also important to clarify that a report of a suspected side effect is not in itself evidence that a vaccine caused theadverse eventin question. Such adverse events can occur for other reasons in vaccinated people,as they do in unvaccinated people. With a large proportion ofthe general populationhaving had the vaccines, we expect many reports of conditions occurringat or soon after vaccination.To determine whether a vaccine caused an event, authorities have to assess all the relevant data, including data that might indicate that the condition occurs at a higher ratein vaccinated or recently vaccinated peoplethan in others.As shown in the product information for both vaccines, most side effects are mild, although more serious ones can occur. You note the risk of myocarditis and pericarditis, which EMA has assessed and describedin the product information.3,4All safety information should be considered carefully before administering or recommending vaccination.EfficacyYou say that ‘a fundamental requirement for a vaccine is to stimulate long-term immunity’, noting that ‘if a vaccine only offers protection for less than a year, it falls short of this crucial criterion’.We take from your comment that no vaccine should be authorisedwithout evidence of long-term protection.While long-term protection is always desirable, imposing such a requirement would have severe consequences for public health and put vulnerable people indanger.Establishing long-term protection may also not be feasible and, in the case of COVID-19, will be complicated by the evolution of SARS-CoV-2, a situation that we also observe with influenza.2https://www.ema.europa.eu/en/environmental-risk-assessment-medicinal-products-human-use-scientific-guideline3https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-29-november-2-december-20214https://www.ema.europa.eu/en/documents/prac-recommendation/signal-assessment-report-myocarditis-pericarditis-tozinameran-covid-19-mrna-vaccine_en.pdfWhen EMA recommends the authorisation of a vaccine, it provides information on the data it assessed to help vaccination authorities and healthcare professionals make recommendations to the wider public. Qualitative and quantitative propertiesIn your section‘Lack of declared qualitative and quantitative properties’, you refer to the lack of data on the prevention of transmission rather thanthe qualitative and quantitative propertiesof the vaccines. We have addressed the issue of transmissibility above.Quality of submitted documentationIn arguing against the authorisations of the vaccines, you refer to‘irregularities and illegalities in altering the categorization of medicines’and ‘changes in the rolling review and conditional marketing authorization procedures, as well as modifications to the definitions of vaccines and immunity’.We comment onthese concerns, to the extent that we can,in the sectionsbelow. You also cited a BMJ article by Paul D Thacker about Ventavia, a contract research organisationthat worked on someclinical trialsitesfor Comirnaty.

5EMA, in close collaboration with the US Food andDrug Administration (FDA), looked into the issues reported in the BMJandconcluded that the deficiencies identified do not jeopardise the quality and integrity of the data from the main Comirnaty trial and have no impact on the benefit-risk assessment.The main trial that supported the authorisation of Comirnaty included around 44,000 people and was conducted in about 150 sites around the world.Ventavia enrolled around 1,000 subjects in 3 sites in the United States, representing less than 3% of the total study population. The issues affected one of those 3 sites and mainly concerned a lack of trained staff which resulted in deficiencies such as delays in data entry and queryresolution. The marketing authorisation holder audited the company at the end of 2020, and corrective actions were taken, including oversight visits and hiring of additional staff. These actions were deemed appropriate.Ventavia also recruited participants in studies on the use of Comirnaty in children and as a booster (representing about 1.6% and 3.5% of the total study populations respectively). As with the main study, EMAlooked at the relevant data andconcludedthat the issues reported at the concerned site have no impact on the assessments of the benefits and risks of the vaccine for these uses. The corrective actions taken by the company were put in place before these later trials started enrolling participants. Summaries of product characteristics and package leafletsYou note that the summaries of product characteristics (SmPCs) for Comirnaty and Spikevax ‘are so voluminous that they have become de facto illegible for both doctors and citizens making informed consent impossible’. You also note a similar problem with the package leaflets.These documents have indeed grown in size as new strengths and new adapted vaccines have been approved. EMA is currently considering ways to improve the way information is presented in SmPCs and package leaflets, not only for COVID-19 vaccines but for all medicines evaluated centrally in the EU.We are also looking at other ways to present information in our lay language questions and answers (Q&A) documents (what we call medicines overviews).Good manufacturing practices5Thacker PD. Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial. BMJ. 2021;375:n2635. Published 2021 Nov 2. doi:10.1136/bmj.n2635You 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 concernedmRNA 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.TheCHMPhas acceptedthelatest specificationsproposed by the company.6

5.Legal status of EU authorisations of Comirnaty and SpikevaxYou have raised a number of concerns about EU Regulations and Directives. You question theinitialconditional marketing authorisations of Comirnaty and Spikevax,asyou believe thatRegulation (EU)2019/57, Regulation (EU) No 2020/10438and Regulation (EU) No 2021/7569do not meet the framework laid down:−on environmental risk assessment and reporting in Regulation (EU) No 2001/1810and Directive 2009/41/EC11;−on safety for medicinal products laid down in Directive 2001/83/EC12, Commission Directive 2003/63/EC13and Regulation (EC) No 1394/200714;−concerning the granting of a union licence laid down in Regulation (EC) No 2004/72615and Regulation (EC) No 2008/123416.You also state thatthe changes in Regulation (EU) 2019/5‘should not be used to go outside the framework of existing classification and categorisation, only clarification is allowed, no categories can be added that conflict with the current system, full legislation is needed for that.’Further, you state that ‘the addition of codes/sequences’in Regulation (EU) No 2021/756 ‘conflicts with the classification and categorisation’of Directive 2001/83/EC, Directive 2003/63/ECand Regulation (EC) No 1394/2007.You also assert that parts of Regulation (EU) No 2020/1043 (concerning trials of GMOs for COVID-19) and Regulation (EU) No 2021/756 (concerning variations to marketing authorisations of coronavirus vaccines) are ‘contrary to Articles 141 and 168’of the Treaty on the Functioning of the 6https://www.ema.europa.eu/en/documents/variation-report/comirnaty-h-c-5735-r-0137-epar-assessment-report-renewal_en.pdf7Amending Regulation (EC) No 726/2004, Regulation (EC) No 1901/2006 (concerning medicines for children) and Directive 2001/83/EC8Concerning trials of GMOs for COVID-199Concerning variations to marketing authorisations of influenza and coronavirus vaccines and amending Regulation 2008/123410Concerning GMOs in the environment11Concerning use of GMOs12Concerning human medicines in the EU13Amending Directive 2001/83/EC14Concerning advancedtherapy medicines15Concerning the establishment of the EMA and the centralised procedure16Concerning variationsEuropean Union. Furthermore, you say that Regulation(EU)2019/5 was used in violation of Article 290(1) of the Treaty.We read these concerns as being related to the Regulations and Directives themselves. While EMA is bound by them, we are not in a positionto comment on the appropriateness of Regulations or Directives adopted by Parliament andthe Counciloron their compatibility with the Treaty.With regard to extensions of marketing authorisations, you note that Regulation (EU) No 2021/756(concerning variations to marketing authorisations of influenza and coronavirus vaccines) was adopted after the authorisations of Comirnaty and Spikevax. The implication is that the Regulation does not apply toadaptedComirnaty and Spikevax vaccines. Please note that thetext of the regulation clearly recognises that ‘based on the scientific assessment by the European Medicines Agency, the Commission has thus far authorised several COVID-19 vaccines’,and the Regulation provides for variations to the authorisations of these and future vaccines.You also highlightArticle 19 of Regulation (EC) No 2008/1234 (concerning variations), which states that‘an extension shall either be granted a marketing authorisation in accordance with the same procedure as for the granting of the initial marketing authorisation to which it relates or be included in that marketing authorisation’.Please note that this article does not preclude relying on relevant data from the initial marketing authorisation. Furthermore, and as noted above, the authorisationof the adapted vaccines for Comirnaty and Spikevax are covered by Regulation (EU) No 2021/756, which amends Regulation (EC) No 2008/1234.With regardtoArticle 1 (4) of Directive 2001/83/EC, vaccines are listed as agents used to produce active immunity. You say that there is no evidence that these vaccines provideimmunity (i.e. protection againstinfectionor disease). It istrue thatthe protectionwanes over time asthe virus itself evolves,and thisis one of the reasons why adapted vaccines have been authorised. It is important to note that with SARS-CoV-2, people may be exposed to the virus several times and repeated exposuremay increase the chance of infectionevenin vaccinated people.COVID-19 vaccines also provide protection against severe disease, including hospitalisation. This is particularly important for vulnerable peoplewho are at increased risk.You also state that ‘a vaccine must contain an antigen; this antigen requires its own registration in the Vaccine Antigen Master File (VAMF)’as laid down in Directive 2003/63/EC. ‘The reason for this method’,you say, ‘is that homogeneity and quality and active dose can be determined per treatment. This is not the case with coding sequences.’It is importantto note that for mRNA vaccines, theantigen (the particle that triggers an immune response) is not the mRNA active substance itself but the spike proteinformed after vaccination.That said, we would like to clarify what a VAMF is. EU legislation provides for the option of presenting all required information on a vaccine antigen as a VAMF (i.e.as a stand-alone part of the marketing authorisation application (MAA) dossier for a vaccine). A VAMF is particularly useful when a specific vaccine antigen is used in different vaccines. In such cases, with asingle evaluation ofa VAMF, authorities can assess the same antigenused in several vaccines at the same time. The VAMF system is therefore only aimed at simplifying the evaluation of vaccines,and the use of VAMFs is optional. When the option of a VAMF is not used, companies, like for any other medicine, have to include the relevant information on the vaccine antigen directly in the MAA dossier concerned.You can find more information inthe Guideline on Requirements for Vaccine Antigen Master File (VAMF) Certificationon EMA’s website.176.EMA reflection papersCiting EMA’s Reflection paper on the classification of advanced therapy medicinal products18and EMA’s Reflection paper on criteria to be considered for the evaluation of new active substance(NAS) status of biological substances, you make the following case: that mRNA is considered an example of gene therapy and therefore any significant change in the sequence of mRNA requires a new application.As you noted in your letter, Commission Directive 2009/120/EC does not consider vaccinesagainstinfectious diseases gene therapies, as the aim of vaccination is nottorestore, correct or modify human genes.Furthermore, the extensions to marketing authorisations ofCOVID-19 vaccines are covered by Regulation (EU) No 2021/75

6.Finally, we take note of your call for immediate action to suspend the marketing authorisations of Comirnaty and Spikevax, including the authorisationsoftheadapted vaccines targeting the Omicron XBB.1.5 subvariant.EMA’s CHMP can only recommend suspensions of themarketing authorisationsif the evidence shows that the risks outweigh the benefits. The evidence continues to show that the vaccines provide protection,which is particularly important forvulnerable people. Removing these vaccines as an option for EU Member Statesand for healthcare professionalswithout due regard to available datawould therefore be a great disservice to the EU and to public health.I would like to thank you for writing to the Agencyand I hope this reply addresses your concerns.Yours sincerely,Emer CookeExecutive Director17https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-requirements-vaccine-antigen-master-file-vamf-certification_en.pdf18https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-classification-advanced-therapy-medicinal-products_en-0.pdf

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