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293 result(s) found, displaying 1 to 10
- COVID-19 vaccine safety reportsCOVID-19 vaccine safety report - 09-03-2023Information about the TGA's safety monitoring of COVID-19 vaccines.
- NewsUpdate on effectiveness of monoclonal antibodies against COVID variantsThe TGA is aware of concerns about decreased effectiveness of monoclonal antibodies against the COVID-19 caused by emerging SAR-COV-2 variants. At this stage, the regulatory status of the products remain unchanged in Australia.
- COVID-19 vaccine safety reportsCOVID-19 vaccine safety report - 23-02-2023Information about the TGA's safety monitoring of COVID-19 vaccines.
- Media releasesTGA grants provisional approval to Moderna’s COVID-19 bivalent (SPIKEVAX Bivalent Original/Omicron BA.4-5) booster dose vaccineOn 17 February, the TGA granted provisional approval to Moderna’s bivalent COVID-19 vaccine. This is the second bivalent vaccine targeting the Omicron BA.4-5 subvariants that has been provisionally approved by the TGA
- COVID-19 vaccine safety reportsCOVID-19 vaccine safety report - 09-02-23Information about the TGA's safety monitoring of COVID-19 vaccines.
- Media releasesTGA confirms the performance of Australian approved Rapid Antigen Tests with COVID-19 VariantsThe TGA has confirmed the performance of COVID-19 rapid antigen tests available on the Australian market with COVID-19 variants.
- COVID-19 vaccine safety reportsCOVID-19 vaccine safety report - 27-01-2023Information about the TGA's safety monitoring of COVID-19 vaccines.
- Media releasesTGA grants provisional approval to Pfizer’s COVID-19 bivalent (COMIRNATY Original/Omicron BA.4-5 COVID-19 vaccine) booster dose vaccineThis is the first vaccine provisionally approved by the TGA that is designed to specifically target the Omicron variants BA.4/BA.5 and follows provisional approval of the Pfizer BA.1 Omicron/original bivalent vaccine.
- Media releasesTGA commences evaluation of Moderna COVID-19 vaccine (SPIKEVAX) for potential transition to full registrationThe TGA has commenced evaluation of an application from Moderna Australia Pty Ltd to transition its COVID-19 vaccine, SPIKEVAX, to full registration for the immunisation of individuals 6 years and over, and as a booster dose for individuals aged 12 years and older.
- COVID-19 vaccine safety reportsCOVID-19 vaccine safety report – 12-01-2023Information about the TGA's safety monitoring of COVID-19 vaccines.