EMA answers to Marcel de Graaff (MEP European Parliament)
PDF here
In this letter, EMA states:
The authorised indications 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.
So EMA (who has been very quiet as the vaccine was pushed into every arm, even forced vaccinations were discussed in some countries like Austria) wants to get rid of their responsibility to not have commented on the happenings,
while millions of tax payers funds were fed into the endless pit of pharmaceutical companies to fight a virus with ~1% case fatality rate.
The letter continues:
“mRNA vaccines are not considered genetically modified organisms.”
Yeah, because they are just genTech?
This EMA answer then cites the
“COMMISSION DIRECTIVE 2009/120/EC
of 14 September 2009
amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products“
Where we can read
The risk analysis may cover the entire development.
Risk factors that may be considered include:
the origin of the cells (autologous, allogeneic, xenogeneic), the ability to proliferate and/or differentiate and to initiate an immune response, the level of cell manipulation, the combination of cells with bioactive molecules or structural materials, the nature of the gene therapy medicinal products, the extent of replication competence of viruses or micro-organisms used in vivo, the level of integration of nucleic acids sequences or genes into the genome, the long time functionality, the risk of oncogenicity and the mode of administration or use.Relevant available non-clinical and clinical data or experience with other, related advanced therapy medicinal products may also be considered in the risk analysis.
Even in the
”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”
linked here
They specifically list risks as
Toxicity tests shall be carried out on two species of mammals one of which must be a non-rodent.
If THIS was done, how comes they advertised it as "stays in the muscle"?
Were these risk analyses done properly?
Aren’t vaccines immunological products?
Please prove me wrong and comment with links to studies for
- pharmacokinetics
- mutagenic potential
- embryo/foetal/perinatal toxicity
- carcinogenic potential
Where are the non-human studies on non-rodents?
Do you know our beloved Commission president Ursula von der Leyen, married with Heiko von der Leyen?
”Von der Leyen became the Director of Hanover Clinical Trial Center GmbH in 2005; an academic clinical research organization on the campus of Hanover Medical School.Since December 2020, he is Medical Director of the company Orgenesis which specialises in cell and gene therapies.
Von der Leyen resigned from his position on the supervisory board of Orgenesis in October 2022, after journalists reported that the Italian branch of Orgenesis had received EU research funds in the past.”
This lady then proceeded to write this short document:
Such changes, which include the replacement or addition of a serotype, strain or antigen or a combination of serotypes, strains or antigens, should be considered as variations to the
marketing authorisation in accordance with Commission Regulation (EC) No 1234/2008 (3).Some vaccines are based on nucleic acid technology to produce an immune response. Modifications of those vaccines may include
changes to the coding sequence.The provisions on such variations should be streamlined, especially during a pandemic. In line with the approach
taken with human influenza vaccines, the procedures should apply to all human coronavirus vaccines and follow an
accelerated timetable. However, where the competent authorities request additional data in the course of their
assessment, they should not be required to take a decision until the assessment of that data has been finalised.
(9) During a pandemic, it may be in the interest of public health to process variations on the basis of less comprehensive
data than is normally the case. However, this approach should be subject to a requirement that the data be
complemented subsequently, with a view to confirming that benefit-risk balance remains favourable.
With this letter she opened the door for all the forthcoming “bivalent” and “adjusted” covid mRNA “vaccines” to be streamlined.
You remember the #10mice scandal?
The same in US
8 mice is enough too
You can read more on the XBB variant here*
My brain is not able to comprehend how these products managed to find their way into the market, disseminating falsehoods as if they were undeniable truths. This phenomenon seems to have infiltrated politics, media, and legislation. It's perplexing that even today, there are people who do not have this information and nobody is shouting it from the roof.
Have a nice day
