TGA grants provisional registration for Moderna’s COVID-19 vaccine

On August 9, 2021 the Moderna COVID-19 genetic vaccine (mRNA-1273) called Spikevax (Elasomeran) was granted provisional registration by TGA for use in 18 years and over.  The submission was accepted on 24 June 2021 and approved in just 23 days, a “standard application” takes 255 working days.

This vaccine contains a long excipients list, and like other COVID-19 vaccines under this fast-tracked provisional approval process it too is still under investigation.  Approval was granted “for active immunisation to prevent coronavirus disease-2019 (COVID-19)”, the symptoms, not for the prevention of SARS-CoV-2 the virus.