TGA provisional appro for Moderna's COVID-19 vaccine

Australia’s Therapeutic Goods Administration (TGA) has granted provisional registration to the COVID-19 Vaccine Moderna in Australia for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older, with the news sending the vaccine’s producer, US biotech firm Moderna’s (Nasdaq: MRNA) shares up 17.1% to $484.47 by close of trading yesterday.

Delivery of Moderna’s COVID-19 vaccine to Australia is expected to commence in the second half of September, noted the company, which recorded $5.9 billion in revenues for its vaccine in the first half of this year.

“I want to thank the government of Australia for their collaboration and for the confidence they have demonstrated in COVID-19 Vaccine Moderna with this decision,” said Stéphane Bancel, chief executive of Moderna. “As we seek to protect people around the world with our COVID-19 vaccine, we look forward to continuing discussions with the Australian government about potentially establishing local mRNA manufacturing capabilities,” he added.