by Jeanne A. Rungby. Special doctor.
On 13 March 2024, I received a new 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).
Most questions are answered by referring to generic links that send me into a maze of pages on the EMA (European Medicines Agency) website. LMST seems to be leading me astray.
No questions answered by providing the direct regulatory documentation I requested.
Since this is the second time I have put 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 the gene-changing injections were imposed 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 the EMA's website that this unregulated approach has been extended until 31 December 2024, even though there is no longer a pandemic.
Pfizer chose, in agreement with the EMA and the FDA, to omit the control of manufacturing "process 2" due to the large volume of the vaccine already administered globally. In addition, they chose 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. 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 Danish Medicines Agency had the authority to issue a GMP certificate for these biological gene-modifying substances, which apparently happened without requiring the manufacturer to provide documentation for safety and effectiveness, without knowledge of long-term side effects and mortality. In doing so, the Danish Medicines Agency has failed to make GRP, good regulatory practice.
This omission should lead to the dismissal and accountability of those responsible in the agencies and institutes that contributed to this deception.
The Minister of Health can expect a new letter in which this issue is explained.
The questions are listed below.
1. Can the minister provide documentation that the production of the vaccine by "process 2" meets applicable requirements for both GRP and GMP when tested in an EU authority laboratory or in a national laboratory?
Not answered. No documentation is provided, but it is stated in the response that the EU laboratories check the vaccines for impurities, including DNA. A link is provided to Eudra-GMP, which states that the competent authority to check whether the correct GMP requirements are met in Denmark is, surprisingly, the Danish Medicines Agency. This attempt to lead me astray comes back to LMST itself as the responsible authority. It is thus the Danish Medicines Agency that has issued the GMP certificate for the so-called Covid-19 vaccines that are given in Denmark!
2. What is the limit value in the EU for DNA contamination in connection with the Covid-19 vaccines, taking into account that the contents are packed in LNP?
Not answered. This EU limit value for DNA contamination is not stated, but links are provided that take me to several links, none of which seem to give me an answer to my question.
3. Has this EU limit value been increased or reduced compared to previous limit values for vaccines produced with a different technology? Documentation required.
Not answered.
However, we know from file access that in November 2020 the EMA expressed concern about the content of unspecified "fragments" in the commercial product. An explanation was demanded from Pfizer, which presumably did not appear. The problem was solved just 3 days later by lowering the limit for RNA integrity to 50% ( https://www.wch-denmark.org/udrulningen-af-mrna-vacciner ).
4. Have EU regulatory laboratories carried out distribution studies (pharmacokinetic studies) of the contents of the vaccine itself (BNT162b2) including LNP?
Not answered. It is claimed in the response that distribution studies have been carried out, but no documentation is provided for these.
5. Has there been an increased incidence of different types of cancer in the Danish population in different age groups since the vaccination campaign for Covid-19 was started? Data base wanted?
I am referring to the Danish Health Data Agency with this question.
6. What studies have been carried out to clarify any incorporation of LNP plasmid DNA into the genome of laboratory animals and humans in an EU regulatory laboratory or a national laboratory? Exactly which batch numbers are examined and where?
Not answered.
7. Why was the content of DNA residues and SV40 respectively in the Covid-19 vaccines not part of the informed consent?
In this new response from LMST, it is stated that the DNA and SV40 contamination is considered insignificant and therefore it was not part of the informed consent, but in the previous response from LMST, the contamination clearly came as a surprise to the Danish Medicines Agency 3 years after the approval. Thus they are contradicting themselves in this matter.
8. Which specific reproduction studies are the basis for the LMST rejecting a risk of altering the human genome by affecting germ cells in testicles and ovaries?
Not answered. It is stated that reproduction studies were performed, but the source reference did not indicate integration studies on the germ cells. The study of 22 rats did not rule out the possibility of affecting germ cells in either the mother or the offspring. The authors were employed by Pfizer. ( https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8163337/ )
9. Has the Danish government, the Minister of the Environment or the Minister of the Interior and Health acceded to the regulation on exemption from environmental risk assessment decided by the EU Council on 14 July 2020? (Refer to references 12 and 13 in the 2nd letter to the minister). Documentation required.
Not answered (see introduction)
10. What does the environmental risk assessment carried out before marketing include, and which environmental risk assessments are not carried out (or exempted according to references 12 and 13 in the 2nd letter to the minister)?
Not answered
11. What correspondence has taken place between the EMA and the Danish Medicines Agency, which leads the authorities to believe that it is of no significant importance that Pfizer has not declared these "sections" of SV40 correctly?
Not answered
12. Have EU regulatory laboratories performed genotoxicity studies to ensure that there is no risk to humans associated with the presence of the SV40 fragment linked to antibiotic resistance gene sequences in the vaccine? Documentation required.
Not answered. However, it appears from Pfizer's application for approval in the EMA that no genotoxic studies have been carried out.
13. If it has come as a surprise to LMST and the minister that there are SV40 fragments in the vaccines, why does the minister choose to continue to offer these vaccines to the Danish population, including young people and pregnant women, as the content of the SV40 fragment has not been a part of informed consent?
See answer to question 7.
14. If Pfizer has failed to declare the SV40 sequence in the vaccines, shouldn't this have both legal and financial consequences for Pfizer?
Not answered.
15. Have the above examinations of the deceased's tissues and body fluids been carried out regularly in connection with autopsies since the vaccinations started?
Here, reference is made to the Swedish Agency for Patient Safety.
16. Which specific studies of the effect of the vaccine spike protein on humans have been carried out in EU or national laboratories?
Not answered.
17. Have new studies been carried out in the EU's official laboratories after peer-reviewed studies have been published that show the spike protein's harmful effects?
Not answered.
18. Will the Minister ensure that studies are carried out for the vaccines' fingerprints in the coliform bacteria found in faecal samples and in waste water/sewage to determine the extent of the environmental pollution, including specifically the spread of the antibiotic resistance gene for kanamycin and neomycin?
No action will be taken to initiate these studies, as LMST does not consider this possible antibiotic resistance to be an environmental risk.
19. Based on this new information given in this reply letter, does the minister still consider it justifiable to recommend the vaccines to the Danish population?
The answer is yes, as they are safe and effective.
20. Given that the spike protein has a harmful effect, will the minister take the initiative to implement treatment strategies to "detoxify" the vaccine-damaged and find a treatment that can neutralize these spike proteins and reverse their harmful effect?
The answer is no, as the spike protein is not believed to be harmful.
A direct link to my second full letter to the Danish Minister of Health can be seen here:
The full response from the Danish Medicines Agency can be seen here:
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