Mystery RNA in TGA Agilent Files, Confirmed by the EMA

Lipid nanoparticle specialist and manager of novel mRNA projects Christie Grace reveals the TGA Agilent files released under Australian FOI showing fragments of 'mystery' mRNA detected in Australian vials.

The European Medicines Agency reported on this phenomenon in their 2021 Comirnity report, conceding unwanted protein synthesis may be occurring but concluded that it's too small to worry about:

'Data demonstrates the presence of truncated/modified forms of mRNA at somewhat higher levels in the batches manufactured with the commercial process as compared to material used in clinical trials.'

'...is expected to be too low to elicit an immune response of biological relevance. Indeed, considering the low dose of mRNA (30 µg), the impurities are not considered a safety issue based on general toxicological principles. However, when present in the cell it cannot be excluded that different proteins than the intact full-length spike will be expressed.'

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