TGA approves Moderna COVID-19 vaccine for adults

Moderna’s COVID-19 vaccine has been given provisional approval by the Therapeutic Goods Administration (TGA) for Australians aged 18 years and over, and will join Pfizer and AstraZeneca in the nation’s vaccine rollout. A fourth vaccine made by Johnson & Johnson has also been approved by the TGA but has not been purchased for the rollout.

Prime Minister Scott Morrison said the TGA approval would provide another shot in the arm for Australia’s vaccination rollout.

“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,” the Prime Minister 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.

“Our National Plan is working with the vaccination rollout ramping up, with more than 1.3 million vaccines administered in just one week. Now we have Moderna, Pfizer and AstraZeneca available as well as more doctors, more nurses and more pharmacists to help get jabs in arms.”

The TGA approval notes the Moderna vaccine will require two doses to be administered 28 days apart.

The Australian Government has already secured 25 million Moderna doses, with the first million expected to arrive in September. Planning is underway for these vaccines to roll out through approved pharmacies and other providers.

A total of 10 million doses will be dispatched to Australia in 2021 and a further 15 million booster doses in the first half of 2022.

Minister for Health and Aged Care Greg Hunt said the approval is a further important step forward for Australia’s 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,” Minister Hunt said.

The Australian Technical Advisory Group on Immunisation (ATAGI) COVID-19 Working Group will factor the provisional approval and supplies of the Moderna vaccine into their future advice regarding the COVID-19 vaccine rollout.

The Moderna vaccine is an mRNA vaccine, the same vaccine type as the Pfizer vaccine, which is already in use in Australia.

The Moderna vaccine has been found to have strong efficacy in preventing symptomatic COVID-19 and severe COVID-19 in clinical trials. It is 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.

“It is indeed welcome news to hear of the approval of yet another safe and effective vaccine for COVID-19 in this country,” said Paul Griffin, Director of Infectious Diseases at Mater Health Services, Associate Professor of Medicine at the University of Queensland, and Medical Director and Principal Investigator at Q-Pharm, Nucleus Network.

“While our rollout has faced many challenges, it is clear that supply has been one of the most significant constraints and to have an additional vaccine as an option reduces our reliance on existing supply chains that have not been able to meet demand thus far (keeping in mind of course that the AstraZeneca vaccine is manufactured in Australia so not in limited supply).

“Moderna has demonstrated high levels of efficacy in large clinical trials that have been verified by data arising from extensive real-world experience. Whilst similar to Pfizer in terms of mechanism of action, safety, efficacy and effectiveness, subtle differences include that the interval is four weeks between doses for Moderna as opposed to three typically with Pfizer, and it does appear Moderna has slightly more temperature stability data so is a little easier to transport and store, including for example being able to be stored at fridge temperature for 30 days and room temperature for 12 hours,” he said.

Data to support the use of Moderna’s COVID-19 vaccine in younger Australians, aged 12–17 years, is being reviewed by the TGA and further decisions may be made in the coming weeks.

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