DNA contamination in genetic vaccines

Priority question for written answer P-000183/2026
to the Commission
Rule 144
Petr Bystron (ESN), Anja Arndt (ESN), Irmhild Boßdorf (ESN)

On 6 September 2025, a report[1] was published stating that massive DNA contamination - levels more than 600 times permissible values - had been detected in the mRNA COVID-19 vaccines Comirnaty and Spikevax. It further revealed that some of the DNA contaminants in Comirnaty carry the sequence of the SV40 enhancer promoter, whose potential as a carcinogen has been extensively described in the literature. In addition to its own findings, the report included previous publications in its discussion of the overall issue, so it can be considered the current state of the art. On 5 October 2025, investigations into an aggressive bladder cancer tumour in a Spikevax vaccine recipient were published, showing that this cancer was associated with the integration of a DNA sequence from the plasmid used in the production of Spikevax into the genome of the affected person, which was considered highly likely to be a consequence of DNA contamination in Spikevax[2]. Although the findings of both publications should have been deemed to be safety signals in accordance with guideline EMA/827661/2011, this does not appear to have happened.

• 1.Why was the authorisation of the COVID-19 mRNA vaccines Comirnaty and Spikevax not suspended on the basis of these and other studies suggesting such a cancer risk?
• 2.What do the European Medicines Agency (EMA) and the Pharmacovigilance Risk Assessment Committee (PRAC) plan to do, and how can they justify their actions on this matter thus far?

Submitted: 16.1.2026

• [1] https://pubmed.ncbi.nlm.nih.gov/40913499/.
• [2] https://ijirms.in/index.php/ijirms/article/view/2130/1505.