Suing Pfizer. False Hope . An Unpopular Opinion.

Everyone seems giddy that Pfizer and Moderna can be sued for fraud and contaminated vaccines.

It seems a Michigan court ruled last summer that the PREP act does not protect a manufacturer due to negligence in allowing glass particles in their approved COVID DRUG (Remdesivir) .

Certainly, its hard to justify glass particles in a drug, especially one given IV. This is something that can be detected with proper Quality Control expected of any drug manufacturer.

I am no legal expert so will just assume the courts decision is valid and applies to Pfizer and Moderna as well.

Many of you are familiar with Kevin McKernans great work. Dude has some serious creds with his work on the Human Genome Project working with guys like Eric Lander.

Turns out Pfizer and Moderna both have plasmid contaminants that may be unsafe. Kevins work has been validated by others, including the Health Agency in Canada.  This might not be as clear cut as glass particles though.

You see there is a catch. FDA guidelines of under 10 ng/dose are for DNA larger than 200 base pairs (bp), but Moderna and Pfizer have less than 10 ng/dose if you only count DNA fragments over 200 bp.  It has hundreds of times more than than that if you count all the little bits which can be done with fluorometry ( qPCR cant be used for the smaller fragments, but this is what Pfizer used because FDA guidelines do not cover the small fragments)

Using fluorometry, all vaccines exceed the guidelines for residual DNA set by FDA and WHO of 10 ng/dose by 188 – 509-fold. However, qPCR residual DNA content in all vaccines were below these guidelines

Currently, the US FDA recommends manufacturers of viral vaccines to limit the amount of residual DNA in the final product to below 10 ng/dose for parenteral inoculations and the size of the DNA to below the size of a functional gene, or ~200 base pairs.

https://osf.io/mjc97/

Of course, with multiple doses you are over 10 ng even with qPCR , but the guidelines are per dose.

Kevin states a lot of great reasons why the guideline is inappropriate, which include the use of LNP allowing the smaller DNA to transfect cells , the fact the guideline used to be 1000 times less plasmid DNA (10 pg/dose) before FDA changed that in 1985 , the year before Reagan gave Vaccine Manufacturers a liability waiver, and some other issues.

However, it is known that DNA contamination could trigger an unwarranted innate immune response and may be prothrombotic, particularly for fragments with high GC content. dsDNA may also be a significant factor in ischemic diseases including stroke. While there appears to be a correlation between high DNA contamination and SAEs more research is needed to expand the sample size and elucidate any potential mechanism at work.

That said, FDA makes the final call on this, and courts give them regulatory deference.  Furthermore, FDA provides Pfizer and Moderna with legal cover, so if anyone gets sued its probably going to have to be FDA that is sued.  Thats kind of like suing yourself but much more difficult. Any damages levied will be paid by the tax payer in the unlikely event you can prove it was the plasmid DNA contamination that was responsible for your injury and not LNP’s or spike protein produced by the modified mRNA

Kevin makes one more great point that applies to Pfizer and not Moderna.  Pfizer uses a SV-40 promoter/enhancer. This is a common promoter is used with plasmids to increase expression of antibiotic resistance genes so the E-Coli bacteria plasmids can grow in a medium with antibiotics to keep other bacteria from contaminating the batch.

While the SV40 enhancer facilitates nuclear localization,genomic integration of DNA fragments has yet to be demonstrated for the COVID-19 modRNA products.

Kevin points out that in the documents he has seen that Pfizer has made no mention of SV-40 and indeed, looks like they went out of their way to remove it from documents submitted to FDA.

@Kevin_McKernan

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The important detail I have failed to vocalize about this is that standard plasmid annotation tools like SnapGene automatically annotate SV40. So someone had to spend the time to delete it before handing it in to regulators. Not an accident. Shows intent to deceive

This certainly is suspicious, perhaps even fraudulent. The reason for hiding it is not very obvious to me. After all, FDA and EMA appear to be rubber stamps for Pfizer, and most every other country just follows FDA and EMA. Why would they make a fuss about a promoter everyone expected to be eliminated during DNA purification.   I mean seriously, they didn’t even require testing to show how long the mRNA persists in translation of spike, how much spike is produced, where the spike goes , or how long the spike persists. SV-40 is going to bother them?.

FDA had its orders from Trump. Operation Warp Speed was a Military Operation designed to get the jabs into the arms of humans fast, as in quick, pronto.  FDA took orders, they did not give them.   They followed orders. Safe and Effective.

They knew they were legally protected (*agency staff cant be sued unless they literally murder someone with a knife and get caught with the knife and victims blood on them) and lucrative job offers would be provided after retirement with full government pensions.

*ok, maybe an exaggeration, but its not easy

Sovereign immunity was incorporated into American law, imposing limits on lawsuits against government agencies or employees.

https://www.forbes.com/advisor/legal/personal-injury/can-you-sue-government/

Besides, how do we know the use of SV-40 promoter was not disclosed in other documents or communications not yet released?

I don’t know the answers. But remember, proving fraud is not enough to overturn liability protection. One must prove willful misconduct.

In general, the liability immunity applies to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of medical countermeasures described in a Declaration.  The only statutory exception to this immunity is for actions or failures to act that constitute willful misconduct. 

Willful misconduct is misconduct that is greater than any form of recklessness or negligence.  It is defined in the PREP Act as an act or failure to act that is taken:

• intentionally to achieve a wrongful purpose;

• knowingly without legal or factual justification; and

• in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.  All three of these conditions must be proven with clear and convincing evidence.

• Willful misconduct cannot be found against:

• A manufacturer or distributor for actions regulated by HHS under the Public Health Service Act or the Federal Food, Drug and Cosmetic Act, if HHS chooses not to take an enforcement action against the manufacturer or distributor, or if HHS terminates or settles an enforcement action without imposing a criminal, civil, or administrative penalty;

https://www.phe.gov/Preparedness/legal/prepact/Pages/prepqa.aspx#:~:text=Willful%20misconduct%20is%20misconduct%20that,legal%20or%20factual%20justification%3B%20and

In other words, Pfizer must know that SV-40 promoter contaminants would be present in their manufactured product and that it would cause harm  greater than the vaccines benefit,  and HHS must choose to take an enforcement action against them.

To know this they would have needed to do testing showing harm would be caused and we know they did very little testing because FDA did not require them to do so.

Now it might be argued there is enough evidence in the literature that Pfizer should know SV-40 promoter contamination could facilitate DNA integration and cause problems with those who had been infected with SV-40 and can express the SV-40 tumor antigen genes.

Again, I am no legal expert nor am I am expert on cellular biology, so maybe there is a case to be made, but I don’t think its a slam dunk, at least not without a whistleblower from Pfizer or FDA taking action against them.

Many of you are familiar with Brooks Jackson and her legal case. What you may not know is there is a big reward for whistleblowers who win their case and can prove fraud or willful misconduct on behalf of the government. Up to 30% of the penalties (compensation for damages, fines, etc).  Thats a lot of cheddar if Pfizer can be taken down.  Lot of incentive for someone to come forward but nobody has. In Brooks case she already got fired before her case was filed so she has nothing to lose.  No doubt her lawyers are doing this pro-bono in return for a piece of the award if they win.

https://pete843.substack.com/p/whistleblowers

The problem is these cases take forever to move through the courts, 10 years or more is not unheard of.

Sorry people, you have been screwed. Don’t pin your hopes on the Courts. And elections aren’t going to help you because none of the candidates are talking about the Vaccines, and the leading candidate (Trump) loves his Vaccine.

Of course there is RFK Jr but after giving Reparations to African Americans and bankrolling Israels Wars he probably wont have much left for you.