Joint open letter COGEM and ZKBS on the ERA of new vaccine developments based on samRNAs and VRPs

In this Joint open letter to the European Commission, the Netherlands Commission on Genetic Modification (COGEM) and the German Central Committee on Biological Safety (ZKBS)  express their concerns regarding the authorization of medicinal products containing self-amplifying mRNAs (samRNAs) or viral replicon-particles (VRPs). The letter was written partly in response to the recent market authorisation of a samRNA, while an assessment of the environmental risks was not conducted.

Both committees consider that an appropriate environmental risk assessment of medicinal products based on viral replicons and self-amplifying mRNAs is crucial, both to assess the risks for humans and the environment of self-propagating molecules and to ensure the public’s trust in and acceptance of medicinal products developed using modern biotechnology.

(https://zkbs-online.de/)