COVID-19 vaccine: Pfizer Australia - COMIRNATY (tozinameran) (mRNA)
The TGA has provisionally approved a booster dose of the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for individuals 18 years and older.
On 29 September 2022, the Therapeutic Goods Administration (TGA) provisionally approved a paediatric dose of Pfizer’s COVID-19 vaccine, COMIRNATY (tozinameran), for children aged 6 months to less than 5 years. As seen with older age groups, it is expected that vaccines for younger children will provide protection from the most severe COVID-19 outcomes, such as hospitalisation and death.
This decision follows provisional approval for the use of COMIRNATY for immunisation as a primary course to prevent COVID-19 in individuals 5 years and older on 3 December 2021, and as a booster dose in individuals 5 years and older on 20 September 2022. This paediatric vaccine is made in the same way as the vaccines for older persons, however, it contains a lower amount of active ingredient (3 micrograms).
In making this regulatory decision, the TGA carefully considered data from an ongoing clinical study conducted in the United States. The study, which included over 4500 participants aged 6 months to 5 years, demonstrated that the immune response to the vaccine was similar to that seen in children aged 5 to 12 years. The study also showed that the safety profile in children was similar to that seen in adults with observed side effects being mild.
The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines, an independent committee with expertise in scientific, medical and clinical fields including consumer representation. The Australian Public Assessment Report for this decision will be published in the coming days.
As with all COVID-19 vaccines, the Government’s decision on the use of this vaccine in this age group will be informed by advice from the Australian Technical Advisory Group on Immunisation (ATAGI).
Supporting regulatory documents
The provisional approval pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data.
The following regulatory documents are made available as part of this process:
- Product Information (PI)
- Consumer Medicine Information (CMI)
- COMIRNATY Decision Summary
The decision summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the ARTG.
- AusPAR: COMIRNATY - BNT162b2 (mRNA) - initial provisional registration
An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission.
- AusPAR: COMIRNATY - BNT162b2 (mRNA) - Extension of indication, use in individuals 12 - 15 years and older
- AusPAR: COMIRNATY – Tozinameran (mRNA COVID-19 vaccine) – Booster dose for individuals 18 years and older
- AusPAR: COMIRNATY – Tozinameran (mRNA COVID-19 vaccine) - Extension of indication, use in individuals 5-11 years and older
- AusPAR: COMIRNATY – Tozinameran (mRNA COVID-19 vaccine) – Booster dose for individuals aged 16-17 years old
- AusPAR: COMIRNATY – Toxinameran (mRNA COVID-19 vaccine) – Booster dose for individuals aged 12 to 15 years old
- AusPAR: COMIRNATY – Tozinameran (mRNA COVID-19 vaccine) – Booster dose for individuals aged 5 to 11 years old will be published in the coming weeks.
- AusPAR: COMIRNATY – Tozinameran (mRNA COVID-19 vaccine) – Extension of indication, use in individuals 6 months up to 5 years will be published in the coming weeks
- 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
- COVID-19 vaccine: Information for consumers and health professionals
Post-approval changes to COVID-19 vaccines
- Post-approval changes to COVID-19 vaccines
- TGA approves more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine
- Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved
- Updated storage conditions: -20 °C for 2 weeks