Moderna approved for use in Australia, with 10 million doses coming

Australians will soon get access to a new vaccine against Covid-19 after Moderna was approved, with overseas results promising.

Australia’s medicines regulator has granted provisional approval to another new Covid-19 vaccine, giving Australia a fourth option in its national rollout.

Moderna should soon be deployed alongside Pfizer and AstraZeneca jabs, as well as the Johnson & Johnson vaccine when that receives the final tick of approval.

The Moderna vaccine could ultimately be approved for babies as young as six months.

TGA chief John Skerritt said studies abroad had proved the Moderna vaccine was highly effective in preventing severe Covid-19 illness and deaths.

“We are delighted to have provided regulatory approval to the Moderna vaccine just within the last hour,” Mr Skerritt told reporters in Canberra on Monday.

Results in the US have shown the Moderna jab is proving to be 93 per cent effective against Covid-19 infection, 98 per cent against severe disease and 100 per cent against death.

“That’s really exciting,” Mr Skerritt said.

The federal government hopes the first one million Moderna doses will be available next month.

TGA chief John Skerritt said provisional approval had been granted to Moderna’s coronavirus vaccine on Monday. Picture: NCA NewsWire / Gary Ramage

Orders have been placed for a total of 25 million doses – enough for nearly half of Australia’s total population – with 10 million to be supplied this year, and another 15 million next year.

The doses arriving in 2022 will be booster jabs updated to handle any new variants that arise.

The Moderna jab uses the same modern science as the Pfizer product, mRNA, to prevent serious illness from the coronavirus.

The “m” in the acronym stands for messenger and RNA is ribonucleic acid, which is present in human cells.

The vaccines use the messenger’s information to teach cells how to make spike protein, which is then recognised by the body as foreign, prompting it to build an immune response.

That response then comes in handy if the vaccine recipient is infected with coronavirus because the body already knows how to protect against it.

The TGA recommends administering the vaccines in two doses given 28 days apart.

Monday’s announcement means people aged over 18 will be allowed to get the Moderna jab. The TGA is also looking at allowing it for children as young as 12.

“Australians can be confident that the TGA‘s review process of Spikevax (elasomeran) was rigorous,” the medicine authority said in a statement.

“The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.

“The TGA will continue to actively monitor the safety of Spikevax (elasomeran) and will not hesitate to take action if safety concerns are identified.”

Prime Minister Scott Morrison said 10 million Moderna doses had been scheduled to arrive this year. Picture: NCA NewsWire / Gary Ramage

“We have more jabs in arms and now 10 million Moderna to add this year,” Prime Minister Scott Morrison said on Monday.

“With more than 1.3 million vaccines doses delivered in just one week, that is almost the population of the city of Adelaide.”

Mr Morrison said he was aware Moderna had said it wanted to run a trial to see what the vaccine’s impact would be on children and infants, which he welcomed, but said there had not been a formal application lodged.

“Moderna has made statements, but like many other companies in this business, they are major competitors, they are interested in testing the efficacy of their vaccines in children as young as 6 months,” Mr Morrison said.

“We welcome that. While preschoolers and young children we have to be convinced about safety. As we move to learn more and more about Covid, it is important to understand the role of these vaccines in children.

“At this stage, there has been no application to conduct the clinical trial in Australia. The company made a statement, but there was a number of companies they may consider running a clinical trial, but we will not have an application to run a clinical trial at this stage.”