One million doses of the mRNA COVID-19 vaccine Moderna are set to arrive in Australia next month, with the Therapeutic Goods Administration (TGA) granting provisional approval to the vaccine for adults 18 and over.
Prime minister Scott Morrison announced the approval on Monday, explaining this meant the Moderna vaccine had met the ‘strict standards of safety, quality and efficacy’ of the TGA.
“Our world-class regulator, the TGA, has given the green light to Moderna’s COVID-19 vaccine, finding it safe, effective and the best way to stop severe illness and hospitalisation,” Morrison said.
“Every vaccination saves lives and gets us one step closer to reaching 70 per cent of Australians, aged over 16, vaccinated before the end of the year.”
The Australian Technical Advisory Group on Immunisation (ATAGI) COVID-19 Working Group is yet to approve the Moderna vaccine, which is already being administered to people in the UK, the EU, Canada, the US and Singapore (under either regulatory approval or emergency authorisation).
Health minister Greg Hunt said that he expected ATAGI’s final advice soon, which would allow eligible Australians to be vaccinated from September 2021.
“Today’s approval is a further important step forward for Australia’s COVID-19 vaccine rollout,” Hunt said.
Moderna will be offered to adults in pharmacies, and the federal government said another 10 million doses have been ordered for delivery in 2021.
The two required doses to be fully vaccinated with Moderna will be required 28 days apart.
The Australian government’s deal with Moderna has secured 25 million doses in total, and the TGA is reviewing data to support the use of this COVID-19 vaccine in children aged 12-17 years. The pm flagged that further decisions about this vaccine would be made in the coming weeks.
Moderna, also known as Spikevax (elasomeran), joins the list of other vaccines against COVID-19 that have received regulatory approval. The other three vaccines are AstraZeneca, Pfizer and Johnson & Johnson (which has not been purchased for Australia’s vaccine rollout).
Biostatistician Professor Adrian Esterman from the University of South Australia said the efficacy of the Moderna vaccine was similar to the mRNA Pfizer vaccine. The main difference between the two kinds of vaccine was the time required between doses, and the quantity difference in a vaccine shot (a single dose of Pfizer contains 0.3 mL of vaccine compared to Moderna’s 0.5 mL).
Even the side effects of the Pfizer and Moderna vaccines were comparable, Esterman added, usually occurring after the second dose.
“With respect to the Delta variant, the Pfizer vaccine has an efficacy of 88% at preventing symptomatic COVID infection after two doses and is 96% effective against severe disease or death. It is expected that the Moderna vaccine will have similar efficacy.
“Both vaccines require two shots, the second Pfizer one being optimally 3 weeks after the first, whereas Moderna it is four weeks,” Esterman said.
From a logistical perspective, Professor Esterman noted that Moderna had a longer shelf life, capable of being stored in refrigeration between 2-8°C for up to 30 days before use. In contrast, Pfizer can only be kept for five days at this temperature.
“With Novavax unavailable until next year, TGA approval of Moderna is welcome news and should provide a big boost to the vaccine rollout,” Esterman said.
University of Queensland’s Associate Professor Paul Griffin, who is also director of infectious diseases at Mater Health Services, said the approval of another safe and effective COVID-19 vaccine was welcome news.
“While [Australia’s vaccine] rollout has faced many challenges, it is clear that supply has been one of the most significant constraints and to have an additional vaccine as an option reduces our reliance on existing supply chains that have not been able to meet demand thus far (keeping in mind of course that the AstraZeneca vaccine is manufactured in Australia so not in limited supply),” Griffin said.
“Moderna has demonstrated high levels of efficacy in large clinical trials that have been verified by data arising from extensive real-world experience.”