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TGA approves booster doses of the Moderna COVID-19 vaccine, SPIKEVAX

8 December 2021

The Therapeutic Goods Administration (TGA) has provisionally approved a booster dose of the Moderna COVID-19 vaccine, SPIKEVAX, for individuals 18 years and older.

The provisional approval means that individuals aged 18 years and older may receive a booster (third dose), at least six months after the completion of a COVID-19 vaccine primary series. This primary series can be of any of the COVID-19 vaccines registered for use in Australia, although data on the use of SPIKEVAX as a booster with other COVID-19 vaccines is more limited.

In addition, the TGA Product Information (PI) also now includes a statement in relation to a 3rd primary dose of COVID-19 vaccine for severely immunocompromised people aged 12 years and over at least 28 days after the second dose. A 3rd primary dose is intended to address the risk of suboptimal or non-response to the standard 2 dose schedule.

TGA provisionally approved the booster dose following careful evaluation of the available data supporting safety and efficacy. The TGA's decision was also informed by expert advice from the Advisory Committee on Vaccines, an independent committee with scientific, clinical and consumer representation.

The Australian Government continues to encourage individuals to complete a two-dose vaccination schedule as this enables strong protection against severe illness and hospitalisation.

The Australian Public Assessment Report for this decision will be published in the coming days. Further information on the roll out of the booster dose of the Moderna vaccine will soon be published on the Department of Health’s website.

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