Australia’s Therapeutic Goods Administration (TGA) announced Monday that it has granted approval for full registration of Moderna’s Covid vaccine, Spikevax. This is the first Covid vaccine in Australia to receive full registration – the others remain provisionally approved.
From the TGA media release:
As with all medicines, the TGA’s assessment was rigorous, independent and based on evidence. The safety and efficacy of Spikevax is also supported by real-world use in millions of people worldwide, providing reassurance about the safety of these vaccines. Vaccination remains the most effective way to protect yourself from serious disease, hospitalisation and death.
This is the product that currently has 7,442 reported adverse events in DAEN (Australia’s VAERS or Yellow Card database). Thirty-six of these entries are reported deaths.
This is also the product that, on independent reanalysis of its own trial data, was revealed to have a serious adverse event rate of 15 per 10,000 doses.
Read More: Australia Ignores Growing Evidence of Harm to Grant Full Approval to Moderna mRNA Vaccine