Australia’s medical regulator has approved Moderna’s COVID vaccine, with first doses of the world-leading jab expected to arrive in the country next month.
The Therapeutic Goods Administration has given a tick of approval to the American-made vaccine, Prime Minister Scott Morrison announced on Monday afternoon.
“The first one million doses is on track to arrive next month and will go to pharmacies,” Mr Morrison said in a Parliament House press conference.
“This is another important tool that we have in our battle against COVID.”
The TGA has given a provisional approval to Moderna for use in people aged over 18. The vaccine requires two doses, given 28 days apart.
TGA head, Professor John Skerritt, said the regulator had given its official approval just an hour before the announcement.
“The Moderna COVID-19 vaccine has shown strong efficacy preventing symptomatic COVID-19 and severe COVID-19 in clinical trials,” the TGA said in its approval announcement.
Moderna, similar to Pfizer’s vaccine, is an mRNA vaccine. It has a near-identical efficacy rate to Pfizer, more than 94 per cent.
Just a day earlier, Health Minister Greg Hunt had said he expected TGA approval “within the next two weeks”. Mr Hunt said Australia expected a million doses would arrive from “the middle of September”.
That’s an increase on previous government supply ‘horizons’, which forecast about 500,000 Moderna doses in September.
“Moderna is the next vaccine to save lives,” Mr Hunt said on Monday.
Mr Morrison said another three million monthly doses would arrive in October, November and December, for a total of 10 million expected this year. The vaccine is being made overseas, and shipped to Australia.
Australia did not place a Moderna order until May this year. Another 15 million doses, of an updated ‘booster or variant vaccine’, are contracted to arrive in 2022.
Moderna could be approved for use in children. Mr Hunt said on Sunday that the TGA was considering, in a separate approval process, extending access to kids as young as 12. Separately again, Moderna is planning clinical trials for children as young as six months, and is considering Australia as a trial site.
Criticisms of Moderna delay
Moderna’s vaccine is known formally as Spikevax or Elasomeran. The TGA said it is currently approved and in use in the United Kingdom, Canada, the European Union, the United States, Switzerland and Singapore.
The federal Labor party has criticised the government for not moving faster on Moderna, in terms of the sluggishness in striking a deal and then the approval process.
“We welcome that arrival, we’ve been calling for it for months and months now,” Labor’s shadow health minister, Mark Butler, said on Monday.
“Yes, Australians can expect Moderna vaccines to arrive in September but I note that in America, they started using Moderna in December, nine months ago. In France, Germany and Italy in January, eight months ago. In Singapore in March, in the UK and Canada in April, and in Japan in May. ”
“So many of the countries to which we usually compare ourselves have been using the Moderna vaccine for months and months now.”
The TGA said its approval process was “rigorous”.
“Provisional approval of this vaccine in Australia is subject to certain strict conditions, such as the requirement for Moderna Australia Pty Ltd to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment,” the regulator said.