Spikevax gains full approval in Australia

Australian medicines regulator the Therapeutic Goods Administration (TGA) has approved the application from the local subsidiary of US mRNA vaccines specialist Moderna (Nasdaq: MRNA) to transition its COVID-19 vaccine, Spikevax (elasomeran), from provisional to full registration.

Following provisional approval in February 2023, this is the first COVID-19 vaccine to have received full registration, the TGA noted. The application for full approval was filed in January this year

In making this decision, the TGA said it carefully considered long-term follow-up data from a number of studies that confirmed the safety and efficacy for Spikevax. These studies showed a continued immune response after a two000000-dose primary series and booster dose. Importantly, no new safety concerns were identified.