Source: European Parliament
Question for written answer E-002077/2025
to the Commission
Rule 144
Gerald Hauser (PfE)
The Kostaive vaccine (ARCT-154) was approved on 14 February 2025. It is based on a new form of mRNA technology in which the mRNA replicates itself in the body’s cells after vaccination. In contrast to conventional mRNA vaccines, Kostaive contains additional genetic information.
This so-called self-amplifying mRNA technology is not without controversy, particularly due to potential long-term risks such as possible damage to the genome (genotoxicity).
According to the safety plan of the European Medicines Agency (EMA), Kostaive has not undergone any studies of its own that have specifically investigated possible damage to the genome. Instead, data from similar products were used, for example from the active substance ARCT-810, from a fat-based transport envelope (lipid nanoparticles, LNP for short) and from a computer evaluation of another active substance (ATX-126). According to the EMA’s assessment, these results do not indicate any risk of genotoxicity.
- 1.Why are mRNA vaccines – especially self-amplifying ones – excluded from direct genotoxicity studies, and how robust is the data reported pertaining to ARCT-810?
- 2.Does the EMA plan to publish the full study reports on ARCT-810, LNP and the in silico analysis of ATX-126 for independent review?
- 3.What measures is the Commission taking to ensure transparent information on the absence of genotoxic risk of this class of vaccine?
Submitted: 22.5.2025