TGA grants Provisional Registration for AstraZeneca COVID-19 Vaccine

On February 16, 2021 the Australian TGA grants Provisional Registration for the AstraZeneca COVID-19 Vaccine, the second gene-based vaccine approved for use in Australia.

COVID-19 Vaccine AstraZeneca has provisional approval for the indication:

• Active immunisation of individuals ≥ 18 years old 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.
• The decision has been made on the basis of short term efficacy and safety data. [Clinical Trial]
• Continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

“As a provisionally registered product, this medicine will remain in the Black Triangle Scheme for the duration of its provisional registration.”

The TGA made a safety assessment based on clinical trials that used a meningococcal vaccine (MenACWY) as a control, and not an inert, saline placebo.