TGA Australia grants provisional approval to COVID-19 Vaccine, Elasomeran to prevent COVID 19- Moderna Australia Pty. Ltd.

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.

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.|