CANBERRA, Aug 9: The Therapeutic Goods Administration (TGA) has today provided provisional approval of the Moderna COVID-19 Vaccine for use in Australian adults.
The provisional approval of Moderna’s vaccine 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.
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 per cent 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 rollout 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: “Today’s 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.
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 the sponsor, Moderna.
Data to support the use of Moderna’s COVID-19 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.