Green light for Moderna


green light new law approval

TGA grants provisional approval to Moderna, while the government secures a shipment of COVID-19 treatment sotrovimab as another tool in its arsenal to fight the pandemic

The TGA has granted provisional approval to Moderna Australia for its COVID-19 vaccine Spikevax (elasomeran), making it the fourth COVID-19 vaccine to receive regulatory approval in Australia.

Moderna’s mRNA vaccine is now provisionally approved and included in the ARTG for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

The Federal Government has secured 25 million doses of the vaccine, including the supply of 10 million doses of Spikevax (elasomeran) in 2021 and 15 million doses of Moderna’s updated variant booster vaccine in 2022.

It has also secured an initial shipment of over 7,700 doses of the novel monoclonal antibody treatment sotrovimab.

Sotrovimab is still being assessed by the TGA, however Health Minister Greg Hunt said its advanced purchase was supported by the Science and Industry Technical Advisory Group (SITAG), the Federal Government’s expert group advising on COVID-19 vaccine and treatment purchases.

“This treatment has been shown to dramatically reduce hospitalisation and risk of death in adults with mild to moderate COVID-19, who are at risk of developing severe COVID-19,” Minister Hunt said in a statement, referring to pre-print results that are waiting to be peer reviewed.

“Sotrovimab will provide another tool in the ongoing challenge against COVID-19. It will provide an important new way to treat the disease and manage outbreaks across Australia,” he said.

Manufactured by GSK, the drug – if approved – will be the first monoclonal antibody treatment available in Australia for the treatment of COVID-19, with the complete treatment requiring one dose administered via IV infusion.

The European Medicines Agency (EMA) completed its review of sotrovimab for treating COVID-19 in May this year, concluding that the drug can be used to treat confirmed COVID-19 in adults and some adolescents who do not require supplemental oxygen therapy and who are at risk of progressing to severe COVID-19.

This month, the National Institutes of Health (NIH) in the US also added sotrovimab as a recommended treatment for non-hospitalised patients with mild to moderate COVID-19 who are at high risk for clinical progression.

At the current time, Australia’s National COVID-19 Clinical Evidence Taskforce recommends that sotrovimab should not be used for the treatment of COVID-19 outside of randomised trials with appropriate ethical approval.

“Sotrovimab will not be the last of these sorts of announcements. As we did last year, we are constantly looking at what is happening in those new developments. We did that with vaccines. We bought the vaccines prior to or had those purchase agreements with companies before the TGA approval. This is the same sort of thing,” said Minister Hunt.

“This will not be used as a treatment until TGA approves it. They’ll be giving us the guidance about how it will be used. I’m starting a process this week with clinical colleagues to look at clinical guidelines, similar to what we’ve done with the ATAGI process in relation to vaccines, and so we’ll be having the first of those meetings tomorrow,” he said on Sunday.

“This medicine is not for everybody. It is an antibody. It will be mostly aimed at people that are not vaccinated. It will be mostly for people who are at highest risk of severe disease. And it needs to be given early in the treatment course. So it will be very useful in certain circumstances, but it’s not for everyone.”

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