TGA approves Moderna vaccine in Aus adults

The Therapeutic Goods Administration (TGA) has granted provisional approval to Moderna Australia for its COVID-19 vaccine, Spikevax (elasomeran), making it the fourth COVID-19 vaccine to receive regulatory approval in Australia.

The Moderna vaccine is an mRNA vaccine — the same vaccine type as Pfizer, which is already in use in Australia. But there are subtle differences between the two; for example, while Pfizer should be administered in two doses at least three weeks apart, the recommended interval for Moderna is four weeks. Furthermore, Moderna has slightly more temperature stability data than Pfizer and so is easier to transport and store — including being able to be stored at fridge temperature for 30 days and room temperature for 12 hours.

The vaccine has been found to have strong efficacy in preventing symptomatic COVID-19 and severe COVID-19 in clinical trials, and is already being widely used in the United Kingdom, Canada, the European Union, the United States and Singapore, where it has either regulatory approval or emergency authorisation. The provisional approval means it has met all the TGA’s strict standards of safety, quality and efficacy for use in people aged 18 years and over to prevent symptomatic and severe COVID-19.

“Our world-class regulator, the TGA, has given the green light to Moderna’s COVID-19 vaccine, finding it safe, effective and the best way to stop severe illness and hospitalisation,” Prime Minister Scott Morrison said.

“Every vaccination saves lives and gets us one step closer to reaching 70% of Australians aged over 16 vaccinated before the end of the year.”

The Australian Government has so far secured 25 million Moderna doses, with 10 million to be dispatched to Australia in 2021 and 15 million booster doses to arrive in the first half of 2022. The first million doses are expected to arrive in September, to be rolled out through approved pharmacies and other providers. The Australian Technical Advisory Group on Immunisation (ATAGI) COVID-19 Working Group will factor the provisional approval and supplies of the Moderna vaccine into its future advice regarding the COVID-19 vaccine rollout.

“We expect the Moderna vaccine to be available as an option for eligible Australians from September 2021, after final advice from ATAGI is received,” said Minister for Health and Aged Care Greg Hunt.

The provisional approval and inclusion of the vaccine in the Australian Register of Therapeutic Goods (ARTG) was able to be expedited, with the TGA accepting rolling data submissions for review, collaboration with international regulators and proactive work with Moderna. Data to support the use of Moderna’s vaccine in younger Australians, aged 12 to 17 years, is being reviewed by the TGA and further decisions may be made in the coming weeks.

Image credit: ©stock.adobe.com/au/bartsadowski

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