Generic environmental risk assessment of clinical trials with MVA vectors

The modified vaccinia virus Ankara (MVA) is a biologically contained virus with a history of safe use as a vaccine against smallpox. Vectors derived from MVA are used in various clinical applications (such as vaccination), in particular because of their high packaging capacity and high immunogenicity, and because the vector genome does not integrate into the DNA of the host cell.
COGEM has issued advice on clinical trials with MVA vectors on a number of previous occasions. Further to a recent request for advice on a broad licence application for clinical vaccine trials using MVA vectors, COGEM has prepared a generic environmental risk assessment for clinical applications with MVA vectors.
MVA vectors are contained such that they are apathogenic and unable to replicate in humans, which makes further transmission in the environment impossible. Given the properties of the MVA vectors, COGEM is of the opinion that the risks to human health and the environment from clinical trials with these vectors are negligible, provided a number of conditions are met. This generic environmental risk assessment can simplify and streamline the authorisation process, because it can provide the basis for drawing up a set of standard licence conditions (vergunning onder vaste voorwaarden – VoV) for these applications.