Moderna's COVID-19 vaccine (SPIKEVAX) provisionally approved for use in individuals 6 years and older

The Therapeutic Goods Administration (TGA) has provisionally approved the Moderna COVID-19 vaccine, SPIKEVAX, for use in individuals aged 6 years and older.

The decision follows the provisional approvals granted by the TGA to Moderna for the use of SPIKEVAX in individuals aged 12 years and older on 3 September 2021, and on 7 December 2021 the SPIKEVAX booster dose for use in adults 18 years and older.

As for other age groups, the use of this vaccine in children aged 6-11 years should be administered as 2 doses at least 28 days apart. The same vaccine preparation employed for older age groups will be used, however, a lower dose of 0.25 mL (50 micrograms) will be given to children 6-11 years, compared to the 0.5 mL (100 microgram) dose used for those 12 years and older.

In making this regulatory decision, the TGA carefully considered data from the KidCOVE clinical trial, which was conducted at multiple sites throughout Canada and the United States and included up to 4,000 participants aged 6 to 11 years. The study demonstrated 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. The most frequent adverse events seen in clinical trials in children aged 6-11 years were short-term and included injection site pain, redness and/or swelling, axillary (groin) swelling or tenderness, fatigue, headache, fever and muscle pain.

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

Provisional approval of this vaccine for individuals 6 years and older is valid for two years. The approval is subject to certain strict conditions, such as the requirement for Moderna 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