Moderna, Inc. has announced that the Therapeutic Goods Administration (TGA) has granted provisional registration for the use of a booster dose of Moderna’s mRNA Covid-19 vaccine, Spikevax, in Australia for active immunisation to prevent Covid-19 in individuals 18 years of age and older.
The TGA provisional registration follows the authorisation by the U.S. Food and Drug Administration (FDA), the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), Health Canada and other health authorities around the world.
“We would like to thank the TGA for this authorisation and the Government of Australia for its continued confidence in our mRNA platform,” says Michael Azrak, General Manager Australia and New Zealand, Moderna.
“We are grateful for the opportunity to provide Australians with another layer of protection.”
Approval was reportedly supported by data from a Phase 2 clinical study of mRNA-1273 in which the original study that supported approval in Australia was amended to offer a booster dose of Spikevax at the 50 µg dose level to interested participants at least six months following their second dose.
Increased neutralising antibody levels were seen across all age groups in adults.
The safety profile following the booster dose was reportedly similar to that observed previously for dose two of Spikevax.
The Spikevax booster dose is to be administered at least six months after completion of a primary series.
