Labels for COVID-19 vaccines

To enable timely distribution of COVID-19 vaccines, international labels are being used during the initial global rollout, including in Australia.

COVID-19 vaccines are manufactured across multiple global sites. Early batches of COVID-19 vaccines used in the Australian vaccination program will be manufactured overseas and imported into Australia with an international label affixed.

Some information typically present on the Australian label may be absent and/or modified on the international label, as well as additional information present that is not relevant to the Australian context.

Access to Australian-specific information

COVID-19 vaccines registered in Australia will be accompanied by Australian Product Information (PI) and Consumer Medicine Information (CMI) documents. Health professionals and consumers should consult the Australian PI and CMI for each COVID-19 vaccine for information relevant to Australia.

Important Australian-specific information that is likely to be absent from the international labels includes:

• registration number ('AUST R' number)
• S4 signal heading ('PRESCRIPTION ONLY MEDICINE')
• cautionary statement ('KEEP OUT OF REACH OF CHILDREN')
• contact details of the Australian sponsor.

Assessment of international labels

The TGA assesses the international label for each vaccine, and checks that the label contains key information to allow the safe use of the vaccine in Australia.

The TGA will impose conditions on the Australian sponsor to develop and implement an Australian label as soon as practicable.

Further information

AstraZeneca COVID-19 vaccine

• ChAdOx1-S (VAXZEVRIA)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Vaccines - AstraZeneca) Labelling Exemption 2021

Moderna COVID-19 vaccines

• Elasomeran (SPIKEVAX)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) Labelling Exemption 2021 (repealed)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran) Labelling Exemption 2022​​​​​​
• Elasomeran and imelasomeran (SPIKEVAX Bivalent Original/Omicron)
  • ​​​​​​Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran and Imelasomeran) Labelling Exemption 2022
• Elasomeran and davesomeran (SPIKEVAX Bivalent Original/Omicron BA.4-5)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran and Davesomeran) Labelling Exemption 2023

Novavax COVID-19 vaccine

• NVX-CoV2373 (NUVAXOVID)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Novavax) (Biocelect Pty Ltd) Labelling Exemption 2022

Pfizer COVID-19 vaccines

• Tozinameran (COMIRNATY)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Pfizer) Labelling Exemption 2021 (repealed)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine – Pfizer) Labelling Exemption (No. 2) 2021
• Tozinameran and riltozinameran (COMIRNATY Original/Omicron BA.1)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Pfizer) (Tozinameran and Riltozinameran) Labelling Exemption 2022
• Tozinameran and famtozinameran (COMIRNATY Original/Omicron BA.4-5)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine—Pfizer) (Tozinameran and Famtozinameran) Labelling Exemption 2023
• Raxtozinameran (COMIRNATY OMICRON XBB.1.5)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine—Pfizer) (Raxtozinameran) Labelling Exemption 2023