TGA grants provisional determination for Moderna COVID-19 vaccine, Elasomeran

TGA

On 24 June 2021 the Therapeutic Goods Administration (TGA), part of the Department of Health, granted provisional determination to Moderna Australia Pty Ltd in relation to the COVID-19 Vaccine, Elasomeran.

This mRNA vaccine will be considered for the active immunisation to prevent coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, in individuals aged 12 years of age and older. While the vaccine has approval or emergency use authorisation in a number of other countries for older populations, it is currently under review in some of those countries for adolescent populations.

If approved, a complete course of the Moderna vaccine is likely to be two doses given 28 days apart.

The granting of a provisional determination means that the TGA has made a decision that Moderna is now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG). Provisional determination is the first step in the process. It is anticipated that Moderna will submit an application for provisional registration shortly. Importantly, registration and supply in Australia will only commence should the vaccine be approved as safe and effective by the TGA.

The Australian Government has secured 25 million doses of the Moderna COVID-19 vaccine to further diversify Australia’s vaccine portfolio as well as provide access to a booster or variant vaccine should this be required in the future. The agreement includes the supply of 10 million doses in 2021 and of 15 million doses of Moderna’s updated variant booster vaccine in 2022.

This is the second messenger RNA (mRNA) vaccine to be purchased by the Government, mRNA vaccines use a genetic code called RNA to spark the production of the coronavirus’ specific spike protein. Once the mRNA enters the body’s cells, the cells use the instructions contained in the RNA to make the spike protein. Immune cells then recognise the spike protein as foreign and begin building an immune response against it. The RNA from the vaccine does not change or interact with our DNA in any way.

/Public Release. This material comes from the originating organization and may be of a point-in-time nature, edited for clarity, style and length. View in full here.