On January 25, 2021 Australia’s TGA grants Provisional Registration for Pfizer Australia Pty Ltd‘s mRNA COVID-19 Vaccine for 16 years and older, the first vaccine for COVID-19 to receive “provisional approval” in Australia and the first new gene technology vaccine ever used. [1, 2, 3]
COMIRNATY (BNT162b2 [mRNA]) COVID-19 Vaccine has provisional approval for the indication below:
- Active immunisation to prevent 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 depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.
This product, like all provisionally registered products, falls under the TGA black triangle safety monitoring scheme.