COMIRNATY COVID-19 VACCINE (Pfizer Australia Pty Ltd)
Product name
COMIRNATY COVID-19 VACCINE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
32 (255 working days)
Active ingredients
bnt162b2 (mrna)
Registration type
EOI
Indication
COMIRNATY COVID-19 Vaccine (concentrated solution for injection) now also has provisional approval for the indication below:
Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 12 years of age and older.
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. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration