Pfizer's COVID-19 vaccine (COMIRNATY) provisionally approved for use in individuals 5 years and over

The Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use in individuals 5 years and older.

This decision follows the provisional approvals granted by the TGA to Pfizer for the use of COMIRNATY in individuals 12 years and older on 22 July 2021 and the booster dose for use in adults 18 years and older on 26 October 2021.

As for other age groups, the use of this vaccine in children aged 5-11 years should be given in two doses at least 3 weeks apart. However, a lower dose (10 micrograms) will be given to children aged 5-11 years, compared to that used for individuals 12 years of age and older (30 micrograms). To deliver the smaller dose, a different orange-capped vial will be used to vaccinate children. It will be clearly differentiated from the product currently used to vaccinate those 12 years and older.

In making this regulatory decision, the TGA carefully considered data from clinical trials conducted in the United States, Finland, Poland and Spain which included participants 5 to 11 years of age. The study demonstrated effectiveness by showing that the immune response to the vaccine in children was similar to that seen in older age groups.

Clinical trials also showed that the safety profile in children is similar to that seen in adults with the observed side effects being mild. The most frequent adverse events seen in clinical trials in children aged 5-11 years were injection site pain, fatigue, headache, injection site redness and swelling, muscle pain and chills.

Further advice on the rollout of COMIRNATY to this age group will be provided to Government by the Australian Technical Advisory Group on Immunisation (ATAGI).

Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia. The approval is subject to certain strict conditions, such as the requirement for Pfizer to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment.

Australians can be confident that the TGA's review process of this vaccine was rigorous and of the highest standard. The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.

The TGA will continue to actively monitor the safety of the vaccine in children and adults both in Australia and overseas and will not hesitate to take action if safety concerns are identified. As an extra check, the TGA laboratories will undertake batch assessment of each batch of the vaccine before it can be supplied in Australia.

The TGA will publish the Australian Public Assessment Report for this decision in the coming days.

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400