145. What is the optimal amount of intact mRNA for the vaccine to be effective?

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 (Pfizer’s COMIRNATY and Moderna’s SPIKEVAX) for each age group can be found in the Product Information (PI) document for each COVID-19 vaccine. PIs are available on the TGA’s website (at www.tga.gov.au/covid-19-vaccines). Click on ‘provisional registrations’ and then select the vaccine’s 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.