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 the joint open letter concerning the absence of an environmental risk assessment for the authorisation of self-amplifying mRNA (samRNA) vaccines.

In the previously sent open letter, COGEM and ZKBS raised concerns about the authorisation of medicinal products containing self-amplifying mRNA (SAMRNA) or viral replication particles (VRP). 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. The EC’s response has done little to alleviate the concerns of COGEM and ZKBS regarding  the safety of human health and the environment.