TGA approves booster doses of Moderna vaccine

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 Australian adults 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 third primary dose of COVID-19 vaccine for severely immunocompromised people aged 12 years and over at least 28 days after the second dose. A third primary dose is intended to address the risk of suboptimal or non-response to the standard two-dose schedule.

The TGA provisionally approved the booster dose following careful evaluation of the available data supporting safety and efficacy; the Australian Technical Advisory Group on Immunisation (ATAGI) will now consider whether to approve its use. If approved by ATAGI, it will become the second option after the Pfizer COVID-19 vaccine for Australians who are eligible for a booster.

The news comes just a few days after the TGA announced it had provisionally approved the Pfizer vaccine, COMIRNATY, for use in individuals aged 5–11 years old, indicating the vaccine is safe and effective for use among this age group. Subject to final considerations and recommendations from ATAGI, which are expected in the coming weeks, the Australian Government will start rolling out the Pfizer vaccine to 5- to 11-year-olds from 10 January 2022.

Additionally, the TGA this week granted provisional approval to Celltrion Healthcare Australia for the use of regdanvimab (REGKIRONA) for the treatment of mild-to-moderate COVID-19 in adult patients, making it the fifth COVID-19 treatment to receive regulatory approval in Australia. A monoclonal antibody treatment, regdanvimab is intended to prevent serious outcomes associated with COVID-19. It works by binding to a specific target on SARS-CoV-2 — the spike receptor binding domain protein — and flags it as ‘foreign’ so that other parts of the immune system can help to clear it from the body.

The TGA’s approval of regdanvimab has been made on the basis of short-term efficacy and safety data; continued approval of this indication depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment. To date, the drug has received market authorisation by the European Medicines Agency (EMA), regulatory approval in the Republic of Korea, and emergency use authorisations in Indonesia and Brazil.

Image credit: ©stock.adobe.com/au/Edson Souza

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