On January 20, 2023 Australia’s Therapeutic Goods Administration (TGA) announced that they have , received the first application to transition a provisionally-approved (PA) COVID-19 vaccine to full registration. [1, 2]
Moderna have applied to transition their COVID-19 vaccine (SPIKEVAX) from Provisional to Full registration – for individuals 6 years and over, and as a booster dose for individuals aged 12 years and older!
Moderna’s “Genetic vaccine platform” called “Spikevax (elasomeran, Moderna COVID-19 Vaccine, mRNA-1273)” received Provisional Approval by TGA on August 9, 2021, just 17 months previous, for a brand new technology product.
On August 29, 2022 the TGA announced it had granted PA for Moderna’s bivalent COVID-19 vaccine (elasomeran/imelasomeran, the original virus and the BA.1 Omicron variant) for use as a booster dose [not primary dose] in adults 18 years+.
On January 10, 2023 Australia’s Department of Health stated that “Moderna (original) vaccine is no longer being manufactured”. The “original” formulation is for the code mRNA-1273 or elasomeran, for which PA was granted! [3]
On December 13, 2021, the Victorian government announced an agreement in-principle to build a Moderna mRNA manufacturing plant in Australia to make a “range of mRNA vaccines“, barely 4 months after the TGA first granted emergency (PA) use for this new technology product! [4]
TGA is considering Spikevax – Moderna’s “vaccine platform” for full registration, not the product which was granted PA in 2021. So, irrespective of the specific protein for which the genetic, modified mRNA code tricks the body into making, the TGA appears to be considering all proteins to be “safe” by default!