- Media releasesTGA grants provisional determination for the Moderna bivalent COVID-19 vaccine "SPIKEVAX Bivalent Zero/Omicron"On 27 April 2022 the TGA granted a provisional determination to Moderna Australia Pty Ltd in relation to its bivalent COVID-19 vaccine, elasomeran/elasomeran 0-omicron (SPIKEVAX Bivalent Zero/Omicron).
- Media releasesTGA provisionally approves Pfizer’s COVID-19 vaccine (COMIRNATY), for use as a booster for individual aged 12–15 years oldThe TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use as a booster in individuals aged 12 to 15 years old.
- Media releasesTGA receives application for an increased dose of GlaxoSmithKline’s COVID-19 treatment sotrovimab (XEVUDY) for the BA.2 Omicron sublineageThe TGA has received an application from GlaxoSmithKline (GSK) Australia Pty Ltd for a higher (1000 mg) dose of its COVID‑19 treatment, sotrovimab (XEVUDY)
- NewsThe TGA granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making it the third COVID-19 vaccine to receive regulatory approval in Australia.
- Media releasesThe TGA has issued an infringement notice for $13,320 to Vaxine Pty Ltd of Adelaide for advertising an unapproved COVID-19 vaccine in alleged breach of the Therapeutic Goods Act 1989.