Regulatory specialist unravels COVID-19 vials and clinical trials

Citizen scientists have recently published their analysis of the contents of the novel mRNA COVID-19 vaccine vials, where concerningly high levels of residual DNA fragments were discovered. Coupled with ongoing regulatory issues such as deviations from the initial clinical trial manufacturing process, the safety and purity concerns of the vial contents mount.

Pharmacist and regulatory specialist Maria Gutschi co-authored a pre-print paper highlighting how the unprecedented mRNA injections lack sound manufacturing processes and how basic regulatory standards are inappropriate for this novel biologic.

Gutschi explains that the clinically trialled COVID-19 mRNA vaccines were developed using “process one” – a form of genetic engineering used to make DNA into mRNA – but it’s a cumbersome process.

To remedy this, Pfizer began manufacturing using “process two,” utilizing Escherichia coli (E.coli) in plasmids as a growth method, which could result in vast variances in residual DNA amounts and other impurities found in the final product.

“They couldn’t make it comparable to the original that was done in the clinical trials,” Gutschi details. “We have no comparison directly, clinically, whether you’re going to get the same clinical outcomes based on the product that had a decreased amount of mRNA [from process one].”

This is an issue when you have these vaccines authorized for children, based on data that was extrapolated from trials using process one, which is no longer in use, explains Gutschi.

“You can’t anchor everything back to the original clinical trial like you would for normal drugs and biologics,” she says. “It gets more and more nebulous.”

Part of that nebulous fact is that this should have been treated as a gene therapy product, not a vaccine because as Gutschi explains, it is transfecting. That is, interacting with and introducing new genetic material into the human body.

“You’re bringing a nucleic acid from outside of the body and into the cytosol. That’s transfection. There are different ways of doing it – lipid nanoparticles are one – and what you’re doing is transfecting and when you do that, that is a genetic product.”

However, regulations and clinical trials were based on vaccine standards, not gene therapy products. This is an issue when it comes to long-term adverse events because the monitoring is more extensive for the former.

“We have this whole new platform,” Gutschi says of standards and regulatory oversight (or lack thereof), “How do you know what is pure if you’ve never done it before?”

Another glaring issue is the SV40 promoter-enhancer housed within the Pfizer vials that was not disclosed to Health Canada.

“The SV40 – just the fact that it is there, even if it doesn’t do anything – is an adulteration,” explains Gutschi. “The second part of that is that the SV40 has been used for gene therapy experiments, it is known to cross into the nucleus and it’s small, it’s only 72 base pairs,” which means that Health Canada’s method of testing (qPCR) wouldn’t have picked it up.

This is serious, she says, because it’s a requirement under the Food and Drug Act (FDA) that drug manufacturers disclose the material parts of their products. “It’s what I would call an adulteration because it was not disclosed. It’s an added thing that was not on the label.”

“Regulatory compendial standards need to be set higher, better and reviewed so that this does not continue. At the very minimum, we also need to determine if this is a risk for patients,” Gutschi concludes.