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The mystery of the missing phase 3 trials.

Updated: Aug 9

By Jeanne A. Rungby, medical specialist.



Drawing by Lars Bo A. Wildernessstate.com

 

When it emerged in early 2023 that independent researchers had found contamination with plasmid DNA and SV40 in Pfizer's Covid-19 genetic vaccines, the world became seriously concerned (1, 2, 3, 4).

Plasmid DNA originates from the manipulated genetic material found inside faecal bacteria (coli bacteria). How could it be found in vaccines, which according to the EMA (5), the Danish Medicines Agency (6) and the product summary (7) only contain mRNA and lipids?

 

The first clinical phase 3 trial on adults aged 16-54, which the product summary refers to (7), was based on a method that does NOT involve coli bacteria, but rather the PCR method where mRNA is multiplied. A much cleaner method.

 

The product summary is used by the vaccinators as part of the instructions for the informed consent.

 

Then the discovery of plasmid DNA revealed that the product summary was not in accordance with the truth. The authorities have thus not informed the vaccinators correctly (8). Are these vaccinators aware that they have injected gene-altering substances into the bloodstream of their fellow human beings (9)?

 

It was clear that the method used for the production of these so-called vaccines was completely different from the one originally approved for.

Pfizer's own designation of the first method is called process 1, and the second method is called process 2. According to Pfizer itself, follow-up of the 252 test subjects who received vaccines from process 2 was stopped (9). And they were not compared to a placebo, ie. control test subjects who only received saline (3).

 

Despite this, both the EMA and the Danish Medicines Agency have approved these genetic vaccines and have NOT OBJECTED when the production method was changed without an associated phase 3 study (5), denying the importance of the contamination that came with the change.

 

Plasmid DNA is far more dangerous to get into the bloodstream than naked DNA, on which the limit values used are based. The amounts of plasmid DNA found in these vials exceeded the limits for naked DNA by several hundred fold.

The use of SV40 is usually used in gene therapy in cases of incurable cancer (3). This is a small part of the Simian Virus from monkeys.

SV40 works by pulling foreign DNA into cell nuclei, where the human genome resides, solely for the purpose of altering the genome (3).

The independent researchers also found genetics from antibiotic resistance in the vials they examined, testifying to an unfinished and sloppy clean-up process.

These antibiotic resistance genes used in the manufacturing process cause the coliform bacteria to divide faster. This makes the production of the "vaccines" cheaper. There is a risk of them spreading to the intestinal microbiome.

When coli bacteria are used in the production, there will also invariably be impurities, the so-called endotoxins, in the "vaccines", which is very dangerous and can cause anaphylactic shock and other severe allergic reactions.

 

In order to give the authorities and ministers as well as the Regions the benefit of the doubt, I have sent a large number of inquiries to agencies and the Minister of Health, who has not responded personally but through the agencies.

 

Below are the latest series of selected extracts from these queries.

 

Date: 25 July 2024. Mail to Thor Svendsen, Danish Health Authority

 

Thank you for your reply to Michael Lind.

 

You write in the answer that the Covid-19 vaccines have been tested in large placebo trials.

You provide a link.

As far as I know - after numerous document inspections and inquiries - this is not correct.

I have not succeeded in getting either the Minister of Health or the health authorities to provide the relevant references.

But to give you the benefit of the doubt, I've gone through the EMA link below - and a host of side links - to see if there were any references to placebo-controlled studies that I've missed.

We are sent around a labyrinth of pages that repeat themselves in a circular system. One is met with repeated undocumented claims that the vaccines have been thoroughly researched and that they are safe and effective.

 

I could not find a randomized, blinded trial tested against placebo for these Covid-19 vaccines as they are mass produced in process 2.

 

The Danish Medicines Agency (by Jakob Lundsteen) has confirmed in writing that they - LMST - did not object when the manufacturer changed from process 1 to process 2.

 

The animal studies and human studies that I have reviewed are either evaluated on the basis of manufacturing process 1 (PCR) or it is not stated which process the vaccine is manufactured by. Incidentally, these studies were all carried out by or with the support of the manufacturer.

 

You are therefore requested to answer the following questions precisely:

 

What placebo-controlled randomized clinical trials in humans (phase 3) exist where process 2 is used in the manufacture of the vaccine on which the conditional or final approval is based? This applies to both Pfizer and Moderna's vaccines. Direct references to scientific phase 3 studies are desired.

 

With best regards

Jeanne A. Rungby, specialist doctor.

 

Date: 29 July 2024. Mail from Thor Svendsen, Danish Health Authority.

 

Dear Jeanne A. Rungby

 

Thank you for your follow-up response regarding documentation that there are small placebo trials in connection with the approval of the vaccines.

I can see that the links I have sent do not directly say anything about placebo trials.

 

But it is normal practice that medicines are only approved after phase 3 trials. And phase 3 trials are usually what you call double-blind placebo trials.

In other words, large experiments where you give a large group of people or the medicine and injection with saline. Neither the subjects nor the healthcare professionals who inject know what is being given.

 

My colleagues in the Danish Medicines Agency's section from clinical trials have helped me find a more relevant link:

It is an international database of all the clinical trials that have been notified.

That is both trials in connection with the approval of the vaccines and trials carried out by independent researchers.

If results emerge in some of these trials that have an impact on the approval of the medicines - including whether we need to change something in the product information - we as the authorities will take this into account.

As can be seen from the above link, 402 different clinical trials have been conducted with mRNA vaccines.

Some of these are placebo trials.

 

I hope this provided a little better documentation.

  

With best regards

 

Thor Svendsen

Team leader

 

The National Board of Health

Information center

9359 6423

 

The information center answers inquiries to both the Danish Medicines Agency and the Danish Health Authority

 


T +45 72 22 74 00

 

If any of you out there have 4-5 months of full-time leave with a scientific background, then you are welcome to review the 402 scientific papers that the Danish Health Authority refers to for clarification of the following:

1. The study refers to process 2.

2. The study is based on a sufficient number of test subjects.

3. The studio is independent of the producers.

4. The study documents that the so-called vaccines are actually safe and effective for everyone.

5. That the study was carried out prior to and forms the basis of the approval.

 

These requirements should be minimum requirements for mandating such a "vaccine" for the entire world's population, including pregnant women and children.

 

However, I must conclude that I have not yet received a clear answer to my questions and that Thor Svendsen, i.e. The Danish Health Authority cannot answer my question regarding the relevant studies.

 

 

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