Drawing by Lars Bo A
The Danish Medicines Agency has declared that the Covid-19 vaccines are not experimental. But they cannot provide documentation for the control studies that should have been carried out.
By Jeanne A. Rungby, Specialist.
Repeated letters and access to documents from Michael Lind and the undersigned have not resulted in documentation, just undocumented claims.
Therefore the following letter is written to
Team leader Thor Svendsen
With copy to
CC The Minister of Health Sophie Løhde, Jacob Lundsteen (The Danish Medicines Agency) and others.
Regarding lack of evidence and lack of regulatory control as well as extensive contamination of the Covid-19 vaccines. We hereby request access to the following questions.
On 14 June 2024, you answered the following to Michael Lind in response to his question about whether the Covid-19 vaccines, which you approved for the Danish population, are experimental.
You answer Michael Lind as directly quoted:
“It is not correctly understood (that the vaccines are experimental). Before the mRNA vaccines were approved, extensive clinical trials were conducted.”…
"We (are) as authorities are of the clear opinion that the mRNA vaccines are not experimental treatment, ... it (is) not something we "out of the box" decide. It is based on the extensive approval process the vaccines have gone through in the EMA. In this process, very extensive evidence has been presented for the treatment's effect and side effects."
Your first statement that the Covid-19 vaccines (Pfizer) underwent extensive clinical trials is not correct. This will be justified and documented in the following.
Your second statement. That the Covid-19 (pfizer) vaccines went through an extensive approval process is also not correct. Reasoning follows.
Your third statement, that it is the Danish Medicines Agency's "opinion" that the covid-19 vaccines were not experimental, negates the other two claims, for which you and your colleague Jacob Lundsteen, on behalf of the Minister of Health, have not yet presented documentation.
If the authority has issued a certificate for marketing, "perception" is not sufficient. You have to know.
As a person in authority, you are responsible for your chosen words and have a duty to answer questions from citizens correctly. False information gives rise to liability.
On 13 March 2024, I received my second answer from the Danish Minister of Health to my questions regarding the contamination of Covid-19 vaccines with DNA and SV40. As usual, the answer came through the Danish Medicines Agency (LMST, from Jacob Lundsteen).
Neither question was answered by providing the direct regulatory documentation I requested.
Since it was the second time I asked these questions to the Minister of Health without getting adequate answers, especially regarding product control and environmental regulation, the conclusion must be that
there has been no regular regulatory control of these gene-altering substances, which have been called vaccines.
This conclusion harmonizes well with the fact that the EU Council adopted a regulation in 2020 to exempt the clinical trials and medical products for the treatment of SARS-Covid2 from the environmental risk assessment applicable in the EU. The EMA and the Danish Medicines Agency were aware that genetically modified organisms (GMO) were involved in the production of vaccines and for the treatment and prevention of SARS-CoV2, as the EU Council adopted an urgent decision on 14 July 2020 that the pharmaceutical companies thus did not have to to carry out the prescribed environmental control of these GMO products as long as the pandemic was classified as a pandemic by the WHO and the European Commission.
However, this exception could only come into force if the regulation was adopted at national level in the form of a directive from the then Minister for the Environment.
After searching the website of the Ministry of the Environment, there are no such directives in 2020, before these vaccines were approved for use on the population.
In my opinion, this makes the so-called vaccines illegal. This must be a reasonable assumption, since the Minister of Health fails to answer questions relating to this exception, including whether the then Danish government acceded to this regulation in 2020.
It seems strange and disturbing that the health authorities have not openly communicated this applicable exception to the public prior to the start of the vaccine campaign. This exemption from regulated GMP (good manufacturing practice) allows substances based on GMOs to be injected into humans, under the pretext of a pandemic, without a current environmental risk assessment being carried out. One gets the impression from EMA's website that this unregulated procedure has been extended until 31 December 2024 , even though there is no longer a pandemic.
It is thus obvious that these vaccines are experimental and that your answer is therefore incorrect. Alternatively, you must provide documentation.
I request documentation for the clinical trials regarding process 1 (the PCR method) as they are irrelevant.
The Covid-19 vaccines approved by you were based on manufacturing process 2, as you probably know.
Pfizer chose, in agreement with the EMA and the FDA, to omit the control of manufacturing process 2, which is significantly different from process 1.
Process 2 was only examined for limited adverse event endpoints in 252 test subjects who were not compared to placebo, but rather to test subjects from Process 1, who were also not compared to placebo.
How does this line up with extensive evidence?
In process 1, it was decided to stop all further control of the test individuals. This happened, among other things, because the original randomized study was made unblinded (after a few months) and therefore no longer fell under the definition of a randomized study, but instead became an observational study. This is evident from EMA's website, as already documented in my second letter to the Minister of Health. That decision was against the study protocol and what had already been agreed. This destroyed the possibility of a follow-up safety evaluation as planned. This was in practice a failure of GMP, good manufacturing practice.
The manufacturer then switched to process 2.
Did I understand correctly that you, as the certifying authority, did not object to this change of manufacturing process?
Answers are desired incl. documentation, including any emails between you and EMA.
Would you please explain to me how this omission aligns with your assurance that a comprehensive approval procedure has taken place?
It appears from Pfizer's documents that no biodistribution studies have been carried out on the active substance. Studies have also not been carried out on the effect or possible damage the product has on various organs and whether the product can change genes, affect fetuses in pregnant women, affect fertility or trigger cancer.
Why were these studies not conducted?
If I have misunderstood this, documentation to the contrary is requested.
Why did you choose to approve these vaccines for children and pregnant women?
Documentation is required for the clinical studies based on the correct manufacturing process, with children and pregnant women as test subjects, which is the basis.
It has also recently emerged in a new study from Leipzig, published on May 8, 2024, that the finding of DNA contamination in Pfizer's Covid-19 vaccines exceeds the limit values more than 500 times compared to the permitted limit values given by the European Danish Medicines Agency, EMA.
The two independent researchers, Brigitte König and Jürgen O. Kirchner from Leipzig and Magdeburg, undertook the task of making quantitative measurements of the DNA contamination in the Covid-19 vaccines (Comirnaty/Pfizer). Using fluorescence staining and spectroscopy, the researchers have found these large amounts of DNA. They thus confirm the previously described findings by McKernan and Speicher et al, which are described in my letter of concern to the Minister of Health November 2023
Did you, the Danish Medicines Agency, not know that there were these large amounts of DNA in the vaccines before you gave the marketing authorization?
The two independent researchers have revealed that PEI, the Poul Erlich Institute, has consistently underestimated the amount of DNA in the vaccines by failing to use soap to release all the DNA from the fat pack. They also chose to target the qPCR to a small subsequence of the full plasmid DNA that was used in process 2. The subsequence was approx. 1% of the full plasmid DNA (DNA template). The remaining 99% remained undetermined.
This kind of manipulation of data is called scientific misconduct and will usually be grounds for deprivation of titles.
It thus appears that PEI - against their better judgment - has consistently used a control method that has underestimated the amount of DNA contamination in these vaccines.
PEI was fully capable of understanding that measuring the full amount of mRNA required pretreatment with soap to include those mRNAs that were encapsulated in fat (NLP).
Why did PEI fail to do the same for DNA?
And how could this error escape you at the Danish Medicines Agency?
According to the authors, qPCR is suitable if you want to identify the presence of specific sequences. If, on the other hand, you want to quantify the total amount of DNA in the vaccine, the method is incorrect. Soap and fluorescence spectrometry, as performed for the quantification of mRNA, must be used here.
The authors conclude that PEI's control is designed so that there has been a massive under-registration of the DNA contamination and that this "should be the subject of extensive expert discussions and considerations".
One could sharpen the tone and think that this should have a legal consequence for all involved ministers and control authorities.
I would suggest that you consider your answer carefully, as it may be a liability.
I look forward to more complete answers.
With best regards
Jeanne A. Rungby
Specialist in Otorhinolaryngology
Sources.
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