Reply to reaction EC on joint open letter from COGEM and ZKBS on samRNA vaccines

COGEM and the German ‘Zentrale Kommission für die Biologische Sicherheit’ (ZKBS) have sent a written response to the European Commission’s (EC) reply to their joint open letter concerning the absence of an environmental risk assessment for the authorisation of self-amplifying mRNA (samRNA) vaccines.

In the previous open letter, COGEM and ZKBS raised concerns about the authorisation of medicinal products containing samRNAs or viral replication particles (VRPs). These concerns were partly due to the recent market authorisation of a samRNA vaccine, while an assessment of the environmental risks was not conducted. The EC’s response has done little to alleviate the concerns of COGEM and ZKBS regarding  the safety of human health and the environment.