The Netherlands Commission on Genetic Modification (COGEM) and the German Central Committee on Biological Safety (ZKBS) sent a joint open letter to the European Commission to express their concerns that environmental risks are not assessed prior to market authorisation of self-amplifying mRNA (samRNA) vaccines derived from alphaviruses. samRNA molecules can self-propagate within cells which makes this type of vaccines very effective. samRNAs and similar products are currently under development for numerous medical applications.
Recently, the first samRNA vaccine was approved for the European market. This vaccine is derived from a vaccine strain of Venezuelan equine encephalitis virus (VEEV) and is directed against COVID-19. Despite the viral origin of the samRNA vaccine, no environmental risk assessment (ERA) in accordance with guideline EMEA/CHMP/BWP/473191/2006 was conducted prior to approval of this vaccine.
Without specifically referring to the approval of this vaccine, COGEM and ZKBS are both of the opinion that an ERA is imperative for self-propagating molecules such as samRNAs. Depending on the construct used, specific risks for third parties and the environment may arise from those medicinal products. One potential risk is the formation of so-called virus-like vesicles (VLVs), which can spread within the body. It is currently unclear if transmission to third parties is possible. Notably, VLVs are also being developed as vaccine platforms.
COGEM and ZKBS stress the need to develop guidelines for the ERA of self-propagating molecules to ensure the safety for third parties and the environment. It would avoid legal uncertainties for applicants and companies, and ensure the public’s trust and acceptance of medicinal products developed using modern biotechnology.