Johnson and Johnson EU Annulment Claim

"COVID-19 Vaccine Janssen" has not been shown to directly or successfully lead to active immunisation.

The Robert Koch Institute explicitly states the following on its homepage: "How long the vaccination protection lasts is not yet known. The protection also does not start immediately after vaccination, and some vaccinated persons remain unprotected. In addition, it is not yet known whether the vaccination also protects against colonisation with the pathogen SARS-CoV-2 or against transmission of the pathogen to other people.

No active immunisation has been demonstrated for "COVID-19 Vaccine

Janssen", and the target of passive immunisation is also not available.

"COVID-19 Vaccine Janssen" as a genetically modified carrier virus substance cannot directly trigger an immune response. However, such a direct immune response is an obligatory function for vaccines. "COVID-19 Vaccine Janssen" is a classical prodrug, i.e. the precursor of a drug, which must first be metabolised by the body's own functions - in this case RNA transcription and protein biosynthesis - into the hoped-for functioning drug. This process is known and described for therapeutic drugs (prodrug), but not for vaccines (the term "provaccine" is unknown). This fact that "COVID-19 Vaccine Janssen" requires endogenous activation also rules out the possibility that this gene therapy drug is a vaccine. It is a gene therapy drug that is supposed to have immunostimulatory effects to alleviate severe consequences of infections caused by coronaviruses. The alleviation of disease symptoms are clearly

functions attributed to medicines (including prophylactic), not vaccines. Accordingly, the active substance "COVID-19 Vaccine Janssen" clearly does not fall under the term "vaccine" as defined in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. In fact, the active substance "COVID-19 Vaccine Janssen" corresponds to the definition of a "gene therapy medicinal product" according to Annex I, Part IV (advanced therapy medicinal products), point 2.1. of Directive 2001/83/EC.


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