WHO informal consultation on characterization and quality aspect of vaccines based on live viral vectors, December 2003
Regulatory issues for live viral-vectored vaccines
It was noted that no regulatory guidance document specific to the technical requirements for licensure of these novel vaccines was universally available. However, the European Union (EU) Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Products (3), although aimed at gene transfer products for gene therapy, was noted to encapsulate certain principles applicable to vectored vaccines. Vaccines transferring and expressing antigen genes would also be subject to the requirements of Annex I, Part IV, of EU Directive 2001/83/EC, as amended by Directive 2003/63/EC, (“Legally required testing provisions for advanced therapy medicinal product”), which defines gene transfer products as “products resulting from a set of processes aimed at the transfer, to be performed either in vivo or ex vivo, of a prophylactic, diagnostic or therapeutic gene, i.e., a piece of DNA, to human cells and its subsequent expression in vivo". It was recommended that any proposed guidance on the quality assurance of vaccines based on viral vectors and on the execution of clinical studies should be specific to particular vector categories, e.g. chimeric live viral vaccines, alphavirus-replicon DNA vaccines, modified/attenuated poxvirus vaccines, replication-restricted adenoviral vector vaccines, etc.... click on the link below for the full text.