MARYANNE DEMASI, PHD | 17 Jan 2024
New research has experts angered by the “complete and utter regulatory failure” to ensure patient safety.
After three years on the market and billions of doses later, the mRNA COVID-19 vaccines continue to throw up surprises.
A landmark study, published last December in Nature, has reignited concerns over the safety of the vaccines.
The study, by highly credentialled UK researchers, found that in addition to spike protein, Pfizer’s mRNA vaccine can instruct cells to produce other ‘off-target’ proteins, which are foreign to the immune system.
How does it happen?
The researchers say that ribosomes, which are responsible for decoding the mRNA in cells, can slip and misread the coded instructions about 8% of the time – known as “ribosomal frameshifting.”
They say the ‘glitch’ has to do with how the mRNA in the vaccine has been genetically modified.
Unlike naturally-occurring mRNA, the mRNA that exists in the vaccines has had a ‘uridine’ base replaced with a ‘N1-methyl pseudouridine’ (to stabilise it) and unfortunately, has made it prone to reading errors.
But are these ‘off-target’ proteins harmful?
At a press briefing, the study researchers insisted there were no safety concerns, and that their findings did not indicate the mRNA vaccines were unsafe.
The BBC characterised the glitch as a “harmless tiny slip” in mRNA gene translation.
Science said there was “nothing alarming” about the study, and interviewed experts who reiterated the absence of adverse events associated with these off-target proteins.
However, David Wiseman, a research scientist involved in medical product development, is not so convinced. He, and his co-authors, published their comments in Nature.
I spoke with Dr Wiseman about his concerns and what this research might mean for patient safety.
DEMASI: Thanks for speaking with me Dr Wiseman. How concerned are you about these latest findings?
WISEMAN: I’m very concerned. This raises more questions about the long-term safety of the mRNA vaccines.
DEMASI: Before we discuss what they found, can you explain the purpose of the study?
WISEMAN: Well, these researchers asked a simple question – are the instructions contained within the mRNA of the vaccines being faithfully carried out. Or put another way, does the body make the spike protein it’s supposed to make, as instructed by the mRNA’s code.
It’s like saying here’s a recipe with instructions on how to make a cake – it’s grandma’s cake recipe. These researchers wanted to know if the mRNA could accurately give instructions on how to make Grandma’s cake or whether it would produce a corrupted version of grandma’s cake.
These researchers obviously knew from the literature that modifying some of the bases in the vaccine’s RNA – as was the case for the mRNA COVID-19 vaccines – that it might cause misreads of different kinds. It’s known as ‘frameshifting.’
DEMASI: And what exactly did they find?
WISEMAN: They found the Pfizer vaccine can cause your cells to make proteins that they are not supposed to make – you end up with what I call “Pfrankenstein proteins.”
DEMASI: Because sometimes there are errors in the way the mRNA is read?
WISEMAN: Yes. Imagine the following three-letter English words ABE DAN TEA TON ERA TWO – the letters are like the code on the mRNA. Now instead of starting to read the sentence at the letter “A” of the first word, you frameshift to the next letter – the letter “B.”
That means that all the other letters are shifted to the left and it will give you a new sentence with three-letter words BED ANT EAT ONE RAT etcetera.
So, the new words have a completely different meaning from the original words. This is what happened in the body of some people vaccinated with Pfizer’s product.
New unwanted “off-target” proteins were produced, that actually led to an “off-target” immune response.
DEMASI: So, were these off-target proteins detected in the blood of people who’d been vaccinated?
No, they did not measure these proteins in the blood of people who’d been vaccinated.
These researchers did something similar to what I did with the six English words – they “predicted” what some of these off-target proteins would look like, had there been a problem with frameshifting.
They made these frameshift proteins in the lab – about 30 or 40 of them – pooled them together in a test tube and then exposed them to blood lymphocytes (white blood cells that mount the immune response) taken from people who’d been vaccinated.
What they found in about 25 to 33% of people who’d received Pfizer’s product, was that their lymphocytes, responded immunologically when exposed to these frameshift proteins in a test tube.
It means their lymphocytes had seen the proteins before – their immune system had already been primed from a prior exposure, presumably after that person had received the mRNA vaccine.
DEMASI: They also tested samples from people who’d received the AstraZeneca vaccine and saw no immune reaction – can you explain why?
WISEMAN: The AstraZeneca vaccine is a different technology. It is a DNA vaccine and does not have the uridine modification that is causing the frameshifting in the mRNA vaccine.
So, it’s not surprising that the lymphocytes from people given the AstraZeneca vaccine did not react to these frameshift proteins, because they’d never seen them before.
DEMASI: They didn’t study people vaccinated with Moderna, but would you say the problem is likely to happen with Moderna’s vaccine too?
WISEMAN: Yes, I would because it’s also an mRNA vaccine and contains the same sort of uridine modification as the Pfizer vaccine.
DEMASI: OK, so making proteins you’re not supposed to make sounds bad, but the media coverage seemed to suggest there wasn’t a problem….
WISEMAN: What you have to realise is that your body is being hijacked, not just to produce spike protein, but also to produce other, what I call, “Pfrankenstein” proteins that are completely uncharacterised.
We don’t know what they are, what they do, for how long they’re made or how long they last in the body, and we have no idea what their toxicity is. From the Nature paper however, we do know that these unwanted proteins elicit immune reactions in the body.
DEMASI: What could these immune reactions lead to? You were concerned about autoimmune conditions?
WISEMAN: Yes. These researchers showed that frameshifting could create chimeric proteins. Basically, as the ribosome reads the code for the spike protein, it may slip in the middle of reading the code. So, the first half is spike protein, and the second half is a Pfrankenstein protein.
Now, just imagine one half can still attach to the ACE2 receptor on cells but on the other end, you’ve got this Pfrankenstein protein dangling outside of the cells. Your immune system is going to destroy the cell because it looks foreign, and now you’ve got something that looks like an autoimmune condition.
Or you could have a protein that turns out to be not necessarily identical, but sufficiently similar to another protein in our body like a hormone and it ends up mimicking the hormone’s activity and disturbing your endocrine system.
DEMASI: But the study authors said there were “no adverse events” associated with these frameshift proteins.
WISEMAN: The authors wrote, “…there is no evidence that frameshifted products in humans generated from BNT162b2 vaccination are associated with adverse outcomes.”
But they only looked at 21 people who received Pfizer’s vaccine, so you cannot call that a serious safety study by any stretch of the imagination.
And how did they select these people? The volunteers were part of another government funded study and had not reported undue effects from vaccination. Since they did not study subjects who had reported adverse vaccine effects, the selection of participants was probably biased.
DEMASI: The authors of the study said that with some tweaks they could identify potential slips and reduce reading errors…..
WISEMAN: Right, and this work should’ve been done by the vaccine manufacturers and by the regulators before the product was authorised and given to billions of people. They’ve asked people to take a vaccine, and put it into children and they have no clue what is happening inside the body.
What they’re trying to say now is that there have been no problems identified in 21 people, but in the future there may be problems, so we should just keep studying it.
Are you kidding me? What they’re saying is that ‘we will inject you first and ask safety questions later.’ It’s not good enough.
It’s just like the retired Pfizer executive admitted in a Nature article, “We flew the aeroplane while we were still building it.”
DEMASI: Shouldn’t the drug regulators be all over this?
WISEMAN: This has been a complete and utter regulatory failure. The 2021 WHO guidelines say that for mRNA vaccines the manufacturers have to disclose all the sequences and unexpected reading frames. They were required to have done this work already… The FDA should have been looking at it.
The mRNA vaccines are causing our bodies to produce uncharacterised proteins, with unknown toxicology, that produce an immune response of unknown clinical significance. The dereliction of duty by regulators shows how they’ve sunken to an all-time low.
Note: Interview has been edited for clarity and brevity.
