On April 20, 2021 the WHO held an informal consultation virtual meeting on regulatory considerations for “evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases” – using mRNA/LNP as the vaccine platform technology. [1]
The WHO opening statement reads:
“The global research and development of mRNA vaccines have progressed rapidly in the past few years, with a substantial impetus and major accomplishments occurring following the onset of the COVID–19 pandemic. The authorization/approval of COVID–19 mRNA vaccines and their deployment during the current pandemic have provided remarkable proof of concept of the capabilities and feasibilities of mRNA vaccines for human protection. The potential of mRNA vaccine as a technology to rapidly respond to public health emergencies of infectious diseases, in addition to application for prophylactic vaccines for additional infectious diseases, have underscored the need for international regulatory convergence for RNA vaccines.”
In 2018-2019 there was “considerably less clinical experience with mRNA technologies” in humans and they know see the need to develop “a document on regulatory considerations for the evaluation of mRNA vaccines”, separate to other genetic vaccines.