The Therapeutic Goods Administration (TGA) has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia.
COVID-19 Vaccine AstraZeneca is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for the active immunisation of individuals 18 years and older for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. The use of this vaccine should be in accordance with official recommendations and given in two separate doses. "TGA's regulatory approval allows the second dose to be administered from 4 to 12 weeks after the first. The Australian Technical Advisory Group on Immunisation has recommended that the interval between first and second dose is 12 weeks. However if this interval is not possible, for example because of imminent travel, cancer chemotherapy, major elective surgery, a minimum interval of 4 weeks between doses can be used.
Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia. The approval is subject to certain strict conditions, such as the requirement for AstraZeneca to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment. COVID-19 Vaccine AstraZeneca has been shown to prevent COVID-19 however it is not yet known whether it prevents transmission or asymptomatic disease.
