COMIRNATY ORIGINAL/OMICRON (Pfizer Australia Pty Ltd)
Product name
COMIRNATY ORIGINAL/OMICRON
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
180 (255 working days)
Active ingredients
famtozinameran, tozinameran
Registration type
EOI
Indication
COMIRNATY Original/Omicron BA.4-5 Vaccine has provisional approval for the indication below:
Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARSCoV- 2, in individuals 6 months 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 immunogenicity 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