COMIRNATY ORIGINAL/OMICRON BA.4-5 (Pfizer Australia Pty Ltd)
Product name
COMIRNATY ORIGINAL/OMICRON BA.4-5
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
23 (255 working days)
Active ingredients
tozinameran, famtozinameran
Registration type
NCE/NBE
Indication
COMIRNATY Original/Omicron BA.4-5 Vaccine has provisional approval for the indication below:
As a booster dose for 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 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