TGA provisionally approves Moderna COVID-19 vaccine (SPIKEVAX) for use in children from 6 months

The Therapeutic Goods Administration (TGA) has provisionally approved a paediatric dose of the Moderna COVID-19 vaccine, SPIKEVAX, for use in individuals aged 6 months to less than 6 years (6 months to 5 years).

Currently this mRNA vaccine is provisionally approved for immunisation to prevent COVID-19 in individuals aged 6 years and older (primary series of 2 doses administered at least 28 days apart), and as a booster dose for adults aged 18 years and older. As we have seen with children in older age groups, the TGA expects that vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death.

As with other age groups, the use of this vaccine in children from 6 months should be administered as 2 doses at least 28 days apart. The paediatric vaccine is made in the same way as the vaccines for older persons, however it contains a lower concentration of the active ingredient:

• 6 months to less than 6 years (6 months to 5 years) - 25 micrograms in 0.25ml vial
• 6 to 11 years - 50 micrograms in 0.25ml vial
• 12 years and older - 100 micrograms in 0.5ml vial

Further information relating to dosing, eligibility for booster doses and interchangeability between vaccines can be found in the Product Information (PI) document, available on the TGA website.

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 over 6000 participants aged 6 months up to 6 years. The study demonstrated that the immune response to the vaccine in children was similar to that seen in young adults (18 to 25 years) with a favourable safety profile.

Clinical trials also showed that the safety profile in children is similar to that seen in adults. Most adverse events seen in clinical trials in children aged 6 months up to 6 years were mild-moderate and generally reported after the second dose. These included irritability/crying, redness and/or swelling at injection site, fatigue, fever, muscle pain and axillary (groin) swelling or tenderness.

Provisional approval of this vaccine in this age group 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 through collaboration with our overseas counterparts. If safety concerns are identified, we will take action and promptly provide information to the public. This can include updating information about recognised adverse effects in the approved PI documents, used by vaccine administrators and other healthcare professionals and available on the TGA website. In addition, fortnightly updates are communicated to the public in the COVID-19 vaccine safety report. 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 relating to this provisional approval in the coming days.

Importantly, TGA provisional approval is the first step in consideration of the use of a COVID-19 vaccine in Australia. This decision indicates that the vaccine has met high safety, quality and efficacy standards.

The potential use of this vaccine in the national COVID-19 vaccination program, including use in which, if any, children in this age group is still to be determined. As with all COVID-19 vaccines, the Australian Technical Advisory Group on Immunisation (ATAGI) will provide advice to the Government on these matters in the coming weeks.

Contact for members of the media:

Email news@health.gov.au

Phone 02 6289 7400