First Moderna COVID-19 vaccines to arrive in September as TGA gives green light

First Moderna COVID-19 vaccines to arrive in September as TGA gives green light

The Therapeutic Goods Administration (TGA) has granted provisional approval to another COVID-19 vaccine, which Prime Minister Scott Morrison believes puts Australia on track to having 70 per cent of the population vaccinated by the year's end.

The Administration has granted provisional approval to provide Moderna's Spikevax (elasomeran) vaccine as an immunisation against COVID-19 for individuals aged 18 years and older.

Like Pfizer/BioNTech's Comirnaty vaccine which is currently the preferred option for younger people, Moderna's product is a messenger RNA (mRNA) vaccine.

"We will have 10 million of the Moderna doses arriving before the end of this year," the Prime Minister said.

"The first one million doses is on track to arrive next month and will go to pharmacies. Then we’ll have three million in October, three million in November and three million in December.

"This is another important tool that we have in our battle against COVID."

A further 15 million doses of the Moderna vaccine have been secured for 2022, but the PM is optimistic for the nearer term as well.

"We have more Pfizer, we have more AstraZeneca, and now we have Moderna," he said.

"With more than 1.3 million vaccine doses delivered in just one week, that is almost the population of the city of Adelaide, with 676 pharmacy sites, with 5,765 GPs enlisted and out there providing jabs and providing important advice, and with the state hubs that are in place and rolling out, the national plan to get jabs in arms...is working with a plan to get 70 per cent of Australians vaccinated before the end of the year."

It is recommended that the Moderna vaccine is given in two doses that are administered 28 days apart.

"The Moderna COVID-19 vaccine has shown strong efficacy preventing symptomatic COVID-19 and severe COVID-19 in clinical trials," the TGA stated.

"The vaccine has also received regulatory approval or emergency authorisation in several countries and is being widely used in the United Kingdom, Canada, the European Union, the United States, Switzerland and Singapore.

"Provisional approval of this vaccine in Australia is subject to certain strict conditions, such as the requirement for Moderna Australia Pty Ltd to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment."

The TGA will make a separate announcement in due course about people aged under 18.

"Data to support the use of Moderna’s COVID-19 vaccine in adolescents aged 12 to 17 years are currently under evaluation and no specific concerns have been identified to date," the administration stated.

"Australians can be confident that the TGA's review process of Spikevax (elasomeran) was rigorous.

"The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation."

The TGA highlighted mRNA vaccines use a synthetic genetic code called RNA to give our cells instructions about how to make the coronavirus’ unique spike protein.

"When our body has made the protein encoded by the mRNA vaccine, it then recognises the spike protein as being foreign and launches an immune response against it," the administration stated.

"The RNA from the vaccine does not change, or interact, with our DNA in any way."

Updated at 4:59pm AEST on 9 August 2021.

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