[COPY] Exploring regulatory data sets of the Comirnaty vaccine - 17

A partial answer to some of our questions

This is a copy of the post that was prematurely posted yesterday - with apologies to our readers.

In the spring of 2024, we reviewed the pharmacokinetic studies from Module 4 of Pfizer-BioNTech’s Biological Licensing Application (BLA) submitted to the FDA for its Covid vaccine, Comirnaty.

We consulted the module 4 files here and produced the nine series of posts (9 to 9g). We went on to look at Module 5 (the clinical module) and, a few months later, integrated the whole lot with the MHRA files. A formerly secret deliberation of the committee that supposedly had our backs with the vaccines but was, in fact, busy downplaying possible harms. This is something the Biden administration also engaged in. The tone of the MHRA minutes clearly suggests that both Comirnaty and Vaxzevria would be provisionally registered as a foregone conclusion.

At the end of our 9-series posts, we came up with a series of questions relating to the pharmacokinetics of Comirnaty:

The lipid “excipients” ALC-0315 and ALC-0159 were new. Regulators note the limited experience with these compounds.

1. Whose job is it to close the gap in evidence and ensure patient safety when new experimental compounds are included in vaccines?

Experience of their use in humans was limited. They act as the carriers; the RNA is a different story. The metabolites were found everywhere in the rats’ organs (liver, spleen, ovaries and so on).

The significance of their widespread distribution in humans is unclear, but their concentrations in the liver and ovaries were very high and almost certainly toxic.

2. Does this hold true for humans, too?

3. What is the possible toxicity of LNPs in humans, especially after repeated exposures?

Vaccine particles (antigens, adjuvants, and excipients) are not usually found in many internal organs; they are usually concentrated around the injection site. We are unclear about the half-life, although the EMA seems to think it is long.

4. Is there a dose-response?

5. What is the half-life of mmRNA in the elimination phase in different organs?

6. What happens to the mmRNA in humans in different organs?

One or more of their ingredients are considered carcinogenic.

7. Why were no carcinogenic studies carried out in animal models prior to provisional licensing?

8. Why were no genotoxicity studies carried out in animal models prior to provisional licensing?

Nanoparticles vary widely, and some are toxic, which is concerning. Our understanding of their behaviour in complex biological systems is extremely limited.

9. Where are the postmarketing studies following up on the cancer risk?

The Japanese regulator considers Cominarty as a “powerful drug”. Cominarty is a formulation consisting of tozinameran encapsulated in LNP.

10. Should mmRNA vaccines be classified as a drug?

11. Why is a modified messenger RNA abbreviated to mRNA, which we are taught stands for messenger?

The Japanese regulator reports Pfizer’s explanation that the pharmacokinetics of mmRNA formulation encapsulated in LNP is dependent on the LNP.

12. Is the LNP inert, as Pfizer claims?

The MHRA enabler (formerly a regulator) does not know anything about the metabolism of the nanoparticles or the mmRNA, nor do they hold vigilance data for the Covid vaccine harms, and they know nothing about the rate of underreporting of harms.

13. Whose job is it to ensure patient safety if the regulator/enabler is wilfully ignorant of the evidence of harm at the approval stage of novel vaccines?

There are no published studies of Cominarty in pregnant women. All the regulators report in the package insert that “No data are available yet regarding use during pregnancy” (EMA and MHRA) or “the available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy” (US FDA).

14. Why has the only randomised controlled trial on pregnant women not been published?

15. Why does the messaging to the public differ from what is reported in the package inserts for pregnancy?

As we moved on and more comments and documents became available, it became clear that the evidence for registration was very partial (none in pregnant women, none in fragile individuals, none on viral transmission and none on the vaccine that was actually rolled out).

The toxicity was reported to us by David Jory, our ophthalmologist subscriber, who noticed scores of cases of Guillain-Barré Syndrome (GBS) post vaccination. We reported our findings based on hours of consultation of thousands of pages of regulatory documents and secret deliberations, plus our readers’ comments.

You will find some of the answers in this brief clip from the horse’s mouth: Dr Helmut Sterz, former Pfizer Chief Toxicologist, interviewed at the Corona Investigation in the Bundestag,

The clip of Sterz's statements was posted by Dr Stefan Homburg here:

These points highlight the critical importance of considering the product’s regulatory position and available evidence when forming a view. We acknowledge that for some, this information may come after decisions have already been made. The concerns outlined also provide a clear basis for the regulator to undertake a comprehensive re-evaluation of the evidence and its prior decisions.

This post was written by two old geezers who have tried not to draw conclusions on the risk-benefit of Comirnaty.

The TTE Comirnaty series started on 6 April 2024 and can be found in our archives.

The MHRA and Bell’s Palsy