Ribosomal frameshifting and misreading of mRNA in COVID-19 vaccines produces “off-target” proteins and immune responses eliciting safety concerns: Comment on UK study by Mulroney et al.

"Capsule

We comment on the study by Mulroney et al. entitled: 'N¹-methylpseudouridylation of mRNA causes +1 ribosomal frameshifting.' The study found evidence in mice and humans for the misreading of the modRNA contained within the Pfizer COVID-19 vaccine to inadvertently produce 'off-target' proteins capable of eliciting 'off-target' immune responses. The authors propose that these novel proteins are the result of ribosomal frameshifting occasioned by the substitution of N1-methyl pseudouridine. The authors state that the 'error prone' code is a safety concern with a 'huge potential to be harmful' and that 'it is essential that these therapeutics are designed to be free from unintended side-effects.'

The findings reveal a developmental and regulatory failure to ask fundamental questions that could affect the safety and effectiveness of these products. According to WHO guidelines for mRNA vaccines, manufacturers should provide details of 'unexpected ORFs' (Open Reading Frames). The formation of these off-target proteins is not disclosed in the package insert for COMIRNATY.

The finding that unintended proteins may be produced as a result of vaccination is sufficient cause for regulators to conduct full risk assessments of past or future harms that may have ensued. Given that this study was conducted under the auspices of the United Kingdom Government, we must assume UK regulators, manufacturers, and international regulatory agencies, including FDA, were apprised of the data many months ago. We await their account of what steps they have taken to investigate why the formation of off-target proteins was not discovered sooner, what toxic effects they may have caused and what steps they are taken [sic] to prevent harm in the future and to inform the public of these findings...

4. Commentary

The paper provides evidence for the formation 'off-target' or unintended proteins following vaccination with BNT162b2 due to frameshifting. Given the proposed mechanism, a similar problem is likely to exist for the Moderna product...

The premise for the study reveals a developmental and regulatory failure to ask fundamental questions that could affect the safety and effectiveness of these products. This is no better exemplified by Pfizer’s retired head of vaccine R&D who was quoted in Nature as saying: 'We flew the aeroplane while we were still building it'...

Documents disclosed under the FOIA reveal that three categories of preclinical studies were not performed by Pfizer, relevant to the current findings: 1) secondary pharmacodynamics, 2) safety pharmacology and 3) pharmacodynamic drug interactions, In two of these categories, WHO guidelines were cited in justification (highlight added).

The package insert for COMIRNATY states:

'Each 0.3 mL dose of COMIRNATY (2023-2024 Formula) is formulated to contain 30 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).'

There is no mention of any other kind of protein."