Moderna, the pharmaceutical giant, has promised to provide Australia with 25m doses of its mRNA vaccine.

On face value, it’s a significant, albeit belated, boost to Australia’s vaccine rollout.

So what do we know about the deal so far?

What is the Moderna vaccine and how effective is it?

Formally called mRNA-1273, the Moderna vaccine is an mRNA-type vaccine, made using a similar process as the highly effective Pfizer/BioNTech vaccine.

The Moderna vaccine inserts mRNA, or genetic material, into the body, telling it how to make the “spike proteins” that sit on the outside of the coronavirus. Those spike proteins allow the virus to enter and infect human cells.

The genetic material triggers the body’s immune response.

mRNA vaccines do not, contrary to some claims, alter a human’s DNA.

The Moderna vaccine is highly effective. It has shown 94.1% efficacy against symptomatic Covid-19 and 100% against severe Covid. It also gives 90% efficacy against Covid-19 for at least six months after the second dose. Those results were recorded in clinical trials involving more than 30,000 participants across 99 sites in the US.

It is a two-dose vaccine, and the second shot is usually taken about 28 days after the first.

The vaccine is mainly manufactured at two plants in the US, though Moderna also has operations in Switzerland, with Lonza, and in Sweden with Recipharm.

Like Pfizer, its distribution is complicated slightly by the cold storage temperatures required. It must be stored at -20C, a far more manageable logistical barrier than Pfizer’s, which initially required -80C storage.

Researchers also say the Moderna vaccine is stable for 30 days at temperatures between 2C and 8C.

What has Australia we secured?

Australia’s deal with Moderna, announced overnight, is expected to provide 10m doses to Australia by the end of the year and a further 15m in 2022.

The doses expected this year will be enough to vaccinate 5m Australians, providing a significant boost to the rollout efforts.

The 15m doses will be used as boosters to tackle variants.

What else needs to be done before it can be injected into Australians’ arms?

The Moderna vaccine has passed clinical trials and is in use in nations like the United States and United Kingdom. The regulators in those countries have declared it safe and effective.

But it still requires approval for use in Australia by the Therapeutic Goods Administration (TGA).

Moderna will lodge a submission with the TGA imminently.

Once that submission is received, it will take the TGA roughly three months to approve the vaccine for use, based on the speed shown with AstraZeneca and Pfizer approvals.

The TGA will also conduct batch testing, a form of independent quality assessment, on each shipment of vaccine prior to it being released for use in Australia.

Moderna has announced that it is open to allowing Australia to manufacture its vaccine locally.
Moderna has announced that it is open to allowing Australia to manufacture its mRNA Covid vaccine locally. Photograph: Arnd Wiegmann/Reuters

Why is this such good news for the vaccine rollout?

Australia’s vaccine rollout was thrown into disarray last month when the advice on AstraZeneca, the mainstay of our vaccine program, changed. Extremely rare blood clotting caused the government to reduce the role of AsztraZeneca, focusing its use on those aged 50 and over.

That left those under 50 more reliant on Pfizer, which has been the subject of intense global demand.

This Moderna vaccine goes some way in solving the problem posed by the changed AstraZeneca advice. The vaccine is safe and effective and there is no evidence it is causing the kind of clotting seen in rare cases with AstraZeneca.

There is also another element to this announcement that brings optimism.

Moderna has said it is open to allowing Australia to manufacture its vaccine locally.

That is a huge boon for the government, which has been under pressure to develop mRNA manufacturing capability for some time, but has had little interest from the other mRNA vaccine producer, Pfizer.

Stéphane Bancel, Moderna’s chief executive officer, said: “As we seek to protect people around the world with our Covid-19 vaccine and potentially our variant booster candidates, we look forward to continuing discussions with Australia about establishing potential local manufacturing opportunities.”

The industry minister, Christian Porter, has been at pains to point out that developing mRNA manufacturing capability will take time, not the three to six months that some experts have suggested.

But when, and if, that manufacturing capability arrives, it will reduce Australia’s reliance on imports in a market of huge global demand.

How safe is it?

Clinical trials involving 30,000 people at 99 sites found the Moderna vaccine to be safe to be effective.

It does have minor side-effects, like most vaccines.

Results from clinical trials for people aged 18 to 64 showed fatigue, headaches and muscle soreness were experienced after both the first and second dose.

First dose side-effects

Second dose side-effects

What other vaccines are coming?

Moderna is not the only vaccine on the horizon.

The federal government has also signed an agreement with Novavax for about 51m doses of its protein vaccine.

Those doses were expected to begin arriving in September this year.

But the company is yet to release data from stage three clinical trials and has recently signalled delays in securing approvals. Earlier this week, chief executive Stan Erck said it could not give any indication of a timeline for approvals in a number of countries, including Australia.

“As of today, we are not able to predict a date with precision, so we won’t,” he said, according to the Sydney Morning Herald.

The company is also expected to prioritise securing approvals from US and UK regulators. So the Australian timeline is looking shaky, at best.

Australia is also entitled to 25m doses through the Covax facility, an international purchasing agreement for a wide range of vaccines, and gave an upfront payment of $123.2m.

It is unclear how close Australia is to securing any vaccines through Covax. It is reliant on receiving offers to purchase vaccines as they become available.

There are currently nine vaccines available that may become available through Covax which are made by AstraZeneca, Novavax, Moderna, CureVac, Sanofi, Inovio, Clover Biopharmaceuticals, Institut Pasteur and the University of Hong Kong.

[*]This content first appear on the guardian

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