What the regulators saw and chose to ignore or “shift the goal-posts” to approve – a seminal paper that can be used by experts to “tease out” and develop into “safe and effective” regulations

From here – h/t Dr Alexander:

IJMS | Free Full-Text | mRNA: Vaccine or Gene Therapy? The Safety Regulatory Issues (mdpi.com)

by Helene Banoun, Independent Researcher, 13001 Marseille, France

Int. J. Mol. Sci. 2023, 24(13), 10514; https://doi.org/10.3390/ijms241310514

Received: 9 June 2023 / Revised: 19 June 2023 / Accepted: 21 June 2023 / Published: 22 June 2023

Which is part of:

IJMS | Special Issue : The Future of Drug Discovery and Development (mdpi.com)

The article published on 22 June 2023 has around 8,000 words (around 12 pages) and 119 references, making it reminiscent of the diligence applied by Robert Kennedy jr in books like “The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health”, that described the wanton slaughter of vilnerable children and AIDS sufferers, for the “shit and giggles” of human experimentation.

Indeed, I suggest that it be turned into a book by some intrepid investigative journalist should Helene Baloun not be so inclined! Each of the points can be teased out and developed further by reference to even greater detail by others, such as on SubStack.

The article goes into great depth into the regulation of the mRNA injections, or rather lack of and excuses from regulation, from the defintion and evolution of regulations around gene therapy products (GTPs), gene therapy medicinal products (GTMPs) to pro-drug definitions (drugs that cause reactions, rather than treat directly) and good manufacturing practices (GMPs).

Of particular note in the piece are the studies NOT completed, using past regulations, controls and protocols, as well as studies that SHOULD have been completed in order to ensure “safe and effective” deployment. Most of these omitted studies have been referenced by others, but here they are compiled in one place, with a description of why they are important.

Also of special interest are the references to clinical trials for further mRNA and other experimental treatments:

“.. manufacturers are planning to replace certain “classic” vaccines with mRNA vaccines [2], starting with influenza vaccines. Indeed, Sanofi is launching a clinical trial of the first mRNA-based seasonal flu vaccine candidate [7] and Moderna has many mRNA vaccines in clinical trials (COVID-19, influenza, human metapneumovirus, parainfluenzas, RSV, HCoV, CMV, EBV, HSV, varicella, herpes, HIV, Zika, Nipah), in particular a phase 3 trial of the flu vaccine [8].

.. In addition, cancer “vaccines” are being announced (e.g., Moderna and Merck are partnering in trials of mRNA-4157/V940, an anti-melanoma “vaccine” combined with Keytruda—a monoclonal antibody directed against the programmed cell death receptor, PD-1) that acts by enhancing the ability of the body’s immune system to detect and fight tumor cells, by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating the anti-T cell response, particularly the antitumor response [10]).

We must be very vigilant about the term vaccine associated with therapeutic drugs, particularly with regard to the regulations that apply to them. These therapeutics are not vaccines against infectious diseases and must therefore continue to comply with GTP regulations.”

I wonder how gene editing tools such as CRISPR fit into all this. In my minds eye, I see editors cutting and snipping out cancer cells as well as snipping and replacing “error” cells.

Once again we are running into different regulations applied to different defintions. Gene therapies have different regulations to “vaccines”. In my view, no-one was “vaccinated” with the C19 mRNA or viral vector injections. Regulatory changed the definition of “vaccine” in order to approve the injections in what was mischaracterized as an “Emergency” by the quacks at the WHO, who spurred on by the egomaniacs, Gates and Schwab, were and are pursuing an agenda of the removal of the accountability of all democratic government, for their own ego, power cravings and monetary gains.

Here is a taste of some of the omitted studies/ From the section titled “3. Controls Required by GTP Regulations to Which Anti-COVID-19 mRNAs Were Not Subjected”

.. the endotoxin level was not numerically provided (see above) and the interaction of nucleic acids with the vector was not studied.

.. for a biological drug, a list of biological activities must be provided, and studies of reproductive function, embryo-fetal and perinatal toxicity and mutagenic and carcinogenic potential must be considered. We have seen above that these tests have not been carried out, and that the biological activities of the active ingredient—mRNA—have not been sufficiently described.

.. no carcinogenicity, insertional mutagenensis nor tumorigenicity in in vivo studies were submitted. Embryo-foetal and perinatal toxicity studies may be required if women of child-bearing potential are to be exposed to GTMPs

.. FDA regulations for GTPs [42], a long-term follow-up of adverse events must be performed for at least 5 years for new clinical conditions, such as: new malignancy(ies), new incidence or exacerbation of a pre-existing neurologic disorders, new incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, new incidence of a hematologic disorder and new incidence of infection (potentially product-related)."

In another section: 4.1. Controls Required for a Pro-Drug That Have Not Been Carried Out

“ If anti-COVID-19 mRNAs had been classified as pro-drugs, they would have had to undergo controls concerning the site of transformation and action [18]. It would thus have been detected that the spike protein translated from the mRNA is not only found in the immune cells of the muscle where the mRNA is injected. This point will be discussed below in Section 4.3.1.”

So, are the C19 mRNA injections a “pro-drug”?

From earlier in the article “.. under European and French regulations, a vaccine must contain an antigen, which is not the case for mRNA vaccines. These products could be considered “pro-vaccine”. In fact, mRNA vaccines do not contain an antigen, but make the vaccinee produce it. They can therefore be classed as pro-drugs or “pro-vaccine”.

Section 4 has sub-sections on manufacturing process purity (dropped from 95% to 50%!!!!!), contaminants (impirities), presence of anti-biotic resitant genes (remember the WHO said that anti0biotics were contra-ondicated for the treatment of C19?)

“The DNA plasmid used as a template for mRNA production contains a kanamycin resistance gene [33] (p. 26). Given the significant and variable quantities of contaminating DNA in the drug substance, there is concern that the resistance gene could be integrated into human digestive tract bacteria or somatic cells [37]. If anti-COVID-19 mRNAs had been subject to GTP regulation, these studies would have been carried out.”

SV40 is not mentioned specifically.

There is a section “4.3. Controls Required for GTP That Were Not Performed: Safety Issues Arising from mRNA Pharmacokinetics”

This section details Pharmacokinetics of Anti-COVID-19 mRNAs, Broad Biodistribution Should Have Made the Carrying Out of Controls Required for GTP Essential,

Another section details issues with Genotoxicity, another Clinical Studies and another Vaccinovigilance.

The opening sentence in the “Conclusions” states “Although the principle of action of COVID-19 mRNA vaccines corresponds to the definition of gene therapy products (GTPs), they have been excluded from the regulation of GTPs by the regulatory agencies (US-FDA and EMA) and subjected to the regulation of vaccines against infectious diseases.”

Damning enough, but it goes on “No scientific or ethical justification is given for this exclusion, and there remain inconsistencies in the regulations.”

Sp, who “watches the detectives”? or in this case the bought and paid for health regulators, turned big pharma enablers, who did not do their job during C19 and who are not going to do their job when all the other mRNA injections hit the streets, just like fentanyl hits the streets – wth no policing or enforcement?

Don’t forget that these shenanigans, corrupt practices and bad manufacturing techniwues of toxins are about to be enshrined into national laws across the globe from the combined effects of changes to International Heath Regulations and Pandemic “Accords” – signed by bureacrats with little no medical or scientific track records in achieving ANY positive result in anything – all funded by massive increases in taxes on developed economies – washed through a useless bureacuracy of the WHO interacting with national health systems – and enforced on the thrid world, who would benefit enormously from simple logistics of food transport (there is plenty of food, it is just not in the right places) and clean water. Instead the Cult of Moloch wants to inject them with poisonous concoctions that can only achieve a fraction of the benefit of food, clean water, agricultural infrastructure and the right (NOT woke!!!) education.

Onwards

Please upgrade to paid, or donate a coffee (I drink a lot of coffee) - “God Bless You!” if you can’t or don’t want to contribute. Coffee donations here: https://ko-fi.com/peterhalligan  Buying just one Ko-Fi a week  for $3 is 50 bucks more than an annual $100 subscription!