TGA grants Full Registration of Moderna Spikevax – first COVID-19 vaccine

On 21 April, 2023 Australia’s product regulator the “TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration. This is the first COVID-19 vaccine to have received full registration”, the announcement was made on April 24, 2023. [1]

This full registration is for “elasomeran” the Wuhan variant and not “davesomeran” the omicron variant! [3]

Currently the TGA adverse reporting system DAEN has 7,442 adverse event reports and 36 deaths for this vaccine. [2]

On August 9, 2021 provisional registration was granted to Moderna.  According to the black triangle scheme the product should be under monitoring for minimum of 5 years – 2026!