A vial of the Moderna COVID-19 vaccine (Image: Camilo Erasso/Long Visual Press/ABACAPRESS.COM)

Millions of doses of Moderna’s COVID-19 vaccine have been administered around the world. But Australia’s Therapeutic Goods Administration still won’t give it the green light yet. 

Yesterday Health Minister Greg Hunt said approval could come within two weeks. Shipments will start arriving in September, initially at a trickle.

Once again Australia lags far behind the rest of the world in uptake of a key vaccine. Here’s how that happened:

A brief timeline

First a bit about Moderna. Until last year, the upstart 10-year-old American company was an obscure biotech firm specialising in even more obscure and cutting-edge mRNA vaccine. Its scientists developed the vaccine over a single weekend in January 2020, just two days after Chinese researchers released the virus’s genetic code. 

Accelerated by the Trump administration’s “Operation Warp Speed”, Moderna began phase three clinical trials in July last year, and by November results pointed to 94% efficacy. About the same time, its rival mRNA vaccine Pfizer was getting similar numbers. By December Moderna was being approved for use in the United States and Europe. 

But here in Australia, Pfizer’s reputation as an old, well-established pharmaceutical company led the government’s scientific and technical advisory group to favour it over Moderna.

“We went with Pfizer mainly because of its capacity to deliver and it was not a new company,” secretary of the Health Department Brendan Murphy said in April.

“Experience has shown that [Pfizer] have delivered a lot more vaccine than Moderna,” he said. “Had we had a contract with Moderna we would have had not very much delivered at this time.”

Weeks earlier, Prime Minister Scott Morrison had rejected the need for Australia to buy Moderna. But by May he proudly announced Australia had secured 25 million doses of Moderna to support the back-end of the vaccine rollout, as fears around AstraZeneca rare adverse effects ratcheted up. 

That announcement didn’t tell us when Moderna would be rolled out, but confirmed it would not commence until the TGA had approved it for use. Moderna hadn’t yet applied. Later national cabinet quietly confirmed the doses wouldn’t be widely used until September.

That announcement has been followed by a series of other announcements, from Morrison and the TGA, about the vaccine. In late June, the TGA granted the vaccine provisional approval, the first hurdle to clear. 

At a Senate COVID-19 committee hearing in July, the TGA’s John Skerritt said approval could come by early August. Now we have Hunt’s latest announcement of approval coming within a fortnight. In September, we’ll get just a million doses, with more to come over the rest of the year.

Why the hold-up?

Why did Australia take so long to get Moderna? First, the advice from the scientific and technical advisory group was Australia needed one mRNA vaccine.

Hunt recently said there was no deal available last November other than the one struck with Pfizer. But again, other countries were far more aggressive in pursuing Moderna. Britain bought 5 million doses on the day its interim results were released in November. The US bought 100 million doses in August.

Australia’s regulators have also moved more slowly. When Moderna is inevitably approved, it will have taken about two months for the TGA to decide. Generally, the TGA takes 120 days longer to approve drugs than the US’ Food and Drug Administration. 

Another reason for the delay is Australia still insists on the TGA granting full approval, as opposed to emergency authorisation, which is the level of approval most countries are happy with (although the UK granted Moderna full authorisation months ago).

“We’re not cutting corners,” Morrison said in January. 

At the Senate hearing on July 23, Skerritt suggested they’d encouraged Moderna to apply for approval earlier. He confirmed the TGA’s advisory committee on vaccines — an outside group of experts — would meet again in a week, and while approval would probably come in early August, there were still a lot of provisos. 

Based on Hunt’s most recent statement, it’ll be even later than that.