Moderna’s COVID-19 vaccine has been given provisional approval by the Therapeutic Goods Administration, Prime Minister Scott Morrison says.
- A third COVID-19 vaccine will be added to Australia’s rollout, as Moderna is approved
- One million Moderna doses will arrive in September, with nine million more due later this year
- The regulator says it hasn’t received a formal application to trial the vaccine on children, despite Moderna indicating it would like to do so in Australia
One million Moderna doses are set to arrive next month to be delivered through pharmacies, with a total 10 million doses ordered by the government for 2021.
TGA boss John Skerrit said approval was given to Moderna just in the last hour, making it the fourth COVID-19 vaccine to be approved in Australia.
The third, a single-dose vaccine made by Johnson & Johnson, has not yet been purchased to be used as part of the national rollout.
Provisional approval fast-tracks the use of a medication under strict conditions while a pharmaceutical company completes its final clinical trials.
This pathway is reserved for promising life-saving medicine and can reduce the wait time for a drug by up to two years, the TGA says.
Moderna’s vaccine has only been approved for people over 18, but the TGA said it was evaluating its use in adolescents and no specific concerns have been identified.
Professor Skerrit said Moderna’s results overseas had been encouraging.
“Even after six months it is proving to be 93 per cent efficacious against any infection, 98 per cent against severe disease and 100 per cent against death and that’s really exciting,” Professor Skerrit said.
“None of us has a crystal ball and no medical expert will be able to say, ‘You need to have a booster [shot] on a certain date’, [but] it is exciting to see such sustained activity of that vaccine six months later.”
With Moderna approval, optimism country will hit 70 per cent target this year
The Prime Minister said that with a third vaccine in the arsenal, alongside the Pfizer and AstraZeneca vaccines, the government would be able to ramp up its program and hit its target of vaccinating 70 per cent of the eligible population by the end of the year.
“We have more doctors, we have more nurses, we have more pharmacists, we have more jabs in arms and now 10 million Moderna to add this year, with more than 1.3 million vaccines doses delivered in just one week,” Mr Morrison said.
“The national plan to get the jabs in arms, to implement the national plan, is working.”
Three million Moderna doses are slated to arrive each month from October until the year’s end.
Professor Skerrit also responded to reports Moderna was seeking to trial its vaccine among children as young as six months of age, saying he had not yet received a formal application for the company to do so.
Moderna indicated in its latest financial reports it was considering a vaccine trial on 6,000 children from six months to 12 years old, with Australia listed as a potential trial location.
The TGA has said any application to trial the Moderna vaccine in children would be subject to clear health and safety standards.
A total 25 million Moderna doses have been purchased by the Commonwealth, with 15 million slated to be used in the first half of next year as a booster shot.