Question Number: 277
PDR Number: SQ22-000648
Date Submitted: 21/11/2022
Department or Body: Department of Health
The approved dosages, including active ingredients (amount of mRNA) for each provisionally approved mRNA vaccine (Pfizers COMIRNATY and Modernas SPIKEVAX) for each age group can be found in the Product Information (PI) document for each COVID-19 vaccine. PIs are available on the TGAs website (at www.tga.gov.au/covid-19-vaccines). Click on provisional registrations and then select the vaccines name. The links to the PIs are listed under the Supporting regulatory documents subheading. Specifically, approved dosages for the Pfizer COVID-19 vaccine COMIRNATY (as a primary course and booster dose) are: 30 micrograms for individuals aged 12 years and older 10 micrograms for individuals aged five to 11 years three micrograms for individuals aged six months to less than five years PI: www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021- PI-02442-1&d=20221125172310101. The approved dosage for the Pfizer COVID-19 vaccine COMIRNATY Original/Omicron BA.1 (as a booster dose) is: 15 micrograms of tozinameran and 15 micrograms of riltozinameran for individuals aged 18 years and older PI: www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2022- PI-02178-1. Approved dosages for the Moderna COVID-19 vaccine SPIKEVAX (as a primary course) are: 100 micrograms for individuals aged 12 years and older 50 micrograms for individuals aged six to 11 years 25 micrograms for individuals aged six months to less than six years PI: www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021- PI-01968-1. The approved dosage for the Moderna COVID-19 vaccine SPIKEVAX (as a booster dose) is: 50 micrograms for individuals aged 12 years and older PI: www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021- PI-01968-1. The approved dosage for the Moderna COVID-19 vaccine SPIKEVAX BIVALENT ORIGINAL/OMICRON (as a booster dose) is: 25 micrograms of elasomeran and 25 micrograms of imelasomeran for individuals aged 18 years and older PI: www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2022- PI-01903-1.