Ellen Banun Pharmacist-biologist, former Inserm researcher and member of the Independent Scientific Council (ISC), Ellen Banun presented the preprint article “mRNA: vaccine or gene therapy? Regulatory Safety Issues”. The interview.

Hélène Banun during the conference in Marseille (DR)

Why and since when are injections of mRNA gene products that can interact with the human genome classified as vaccines?

Until 2008, according to regulatory authorities, anything that was nucleic acid was classified as a gene therapy product (GTP) and was subject to very strict rules. Starting in 2009, the agencies decided that anything that is nucleic acid intended for vaccine use against infectious diseases is exempt from the stricter gene therapy rules.

Do we know why?

There was an H1N1 flu pandemic in 2009-2010, and in 2010, Dr. Anthony Fauci (Editor’s Note: Director of the National Institute of Allergy and Infectious Diseases (NIAID), a research center of the US Department of Health) was looking for a universal flu vaccine. In November 2010, there was talk of a DNA (yet not mRNA) vaccine. In 2011, European companies CureVac and Sanofi started cooperation with DARPA (research agency of the US military) to develop mRNA vaccines. In 2013, DARPA awarded Moderna a multimillion-dollar grant to develop messenger RNA therapies against infectious diseases. Regulators then downgraded these products, bringing them under vaccine regulations.

Why should products intended for the world’s healthy population (vaccines) receive less scrutiny than the same products intended for the few people with genetic diseases?

There is no scientific or ethical justification for exempting mRNA vaccines from the strict control to which the GTP is subject (mRNAs intended for the treatment of cancer or genetic diseases and completely identical to vaccines in their principle and formulation are subject to GTP regulation.

Can you explain the differences between the regulatory protocol for the approval of vaccines and gene therapy products?

When mRNA vaccines were developed, there were no specific regulations for this type of product. Moreover, manufacturers Pfizer and Moderna thought they would be approved as gene therapies. Therefore, regulatory agencies (especially the European Medicines Agency – EMA) have added controls to vaccine regulation inspired by those required for GTP (as you can guess from EMA reports). But some controls for GTP were not required. This control is carried out in two directions: product quality and preclinical research.
“All this is not done.

Not all of it is done.

Regarding product quality, the exact nucleotide sequence was not provided, nor was the interaction with the nanoparticle, and the search and quantification of GTP-bound impurities. Teams of independent researchers have found significant contamination of DNA (which serves as a template for mRNA production), which is worrisome in terms of genomic integration; these teams also found an oncogenic virus SV40 promoter that promotes integration into the genome.

As for the preclinical studies (carried out on cells in culture and on animals), for GTP they had to look for integration into the genome, transmission in the germ line. They were to look for toxicity associated with modified protein expression, reproductive toxicity, and biodistribution of the vaccine upon administration (lipid nanoparticles complete with the mRNA in question; however, they tested other mRNAs and only nanoparticle components). All of these controls are important for gene therapy products.

“We know it’s wrong”

If mRNA vaccines were considered as gene therapy products, they should have studied the persistence of mRNA and its product (spiking), the duration of mRNA expression… All this has not been done. We were told that it is injected into the muscle, it stays in the muscle for two days, after which it disappears. We know this is not true (mRNA and vaccine surges are everywhere in the body for weeks). They had to study excretion into the environment, transition from vaccinated to unvaccinated, excretion with sperm… transplacental journey and into breast milk. If it were all done, it would take ten years!

Turnkey plants

What is the purpose of your publication?

So that scientists, lawyers, politicians and citizens know that the problem exists. This is now recognized by regulatory experts. But I am not very optimistic. Because the big labs have decided to develop mRNA factories everywhere, especially in South Africa, where they are creating turnkey factories for the whole African continent (EU-funded factories). So we have to deal with it now. How can we continue to sell these products knowing that if a pregnant woman is vaccinated, the product can pass into the fetus, if the woman is breastfeeding, it passes into the breast milk, etc.?

How can we get politicians, elected officials and managers to care about this problem?

Lawyers should also respond. This must also happen through the justice system. We think Covid is over, but really all the other messenger RNAs are coming in now and we’re continuing to build anti-virus features. They are preparing us for the next pandemics with lab-engineered viruses. It’s not over for those with adverse reactions to vaccines or lingering Covid either.

Hélène Banoun’s article submitted as a preprint provides access to useful links for this interview. It will be revised for publication