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.
““We’re not cutting corners,” Morrison said in January. ”
Cough, cough Great Barrier Reef Foundation, Great Barrier reef Foundation Jobseeker, Sports Rorts, Car Pork Rorts.
And we don’t believe in lockdowns either, just ask my clone Berjikillthem
Norman Swan:
Well, the Premier seems to have changed her language and is no longer talking about getting back to zero spread and talking about having to learn to live with COVID-19, and I think it’s just the reality of day after day with high numbers of cases and high numbers of cases circulating in the community.
And Sydney has got exactly the problem, although it’s a very different set of circumstances in Sydney this year in their second wave from Melbourne last year, it’s going through very similarly structured suburbs where there is a degree of poverty, disadvantage, different cultural groups, not necessarily speaking English as a first language, multigenerational households, and it’s just not coming under control in those areas but it’s spreading elsewhere in the city.
As a counter idea, the eastern suburbs of Sydney, where it originated, has largely Ben free of additional infection for the last 4 weeks. Eastern suburbs, in spite of pictures of Bondi beach, have followed the health advice, and Lo and behold, infections have been suppressed almost to zero. Cultural and education levels in eastern suburbs, and sense of self preservation, clearly higher.
It must be, as stated by Health Hazzard, due to people “of different backgrounds” – not lack of vaccination supply or adequate resources to stay indoors if ill.
So glad that has been made clear.
Wouldn’t you think after fighting covid for the best part of two years, that governments would realise the quickest way to distribute new vaccines is to gain rapid approval, and the best way to do that is work together, using each others’ data, reports and resources? This still-fragmented approach to approval only serves to delay.
Some info
Moderna’s COVID-19 vaccine, also known as mRNA-1273, is a two-dose vaccine. The doses are administered 28 days apart, and the vaccine trains the immune system to fight against future infections with SARS-CoV-2, the virus that causes COVID-19.
Moderna’s vaccine has authorization for use in a total of 53 countries. The Food and Drug Administration (FDA)Trusted Source has issued this authorization for people in the United States aged 18 or older. The vaccine has also been authorized for use across the European Union after a recommendation by the European Medicines Agency, as well as in Canada and the United Kingdom.
Clinical trial data show that the vaccine has an efficacy of 94.1% at preventing symptomatic COVID-19.
The FDA’s fact sheetTrusted Source for this vaccine lists the following general side effects. Also, we have included the percentages of frequency reported in Moderna’s phase 3 clinical trial data:
fatigue (70%)
headache (64.7%)
muscle pain (61.5%)
joint pain (46.4%)
chills (45.4%)
nausea and vomiting (23%)
fever (15.5%)
The clinical trials found that side effects were more commonly reported after the second dose and lasted around 2–3 days.
Recipients also reported the following injection site reactions:
pain (92%)
swelling (14.7%)
swelling of armpit lymph nodes, specifically (19.8%)
redness (10%)
People who have had other authorized COVID-19 vaccines have also reported these side effects.
https://www.medicalnewstoday.com/articles/moderna-covid-19-vaccine-what-to-know-about-side-effects#Common-side-effects
Reports of myocarditis, or inflammation of the heart muscle, and pericarditis, which is inflammation of the lining outside the heart, after the receipt of mRNA vaccines, the FDA added revisions information
Allan, they sound exactly the same as for Pfizer, or is my memory faulty. Seems that the side effects of AZ have been extravagantly reported while Pfizer has has a free run in the media. Would be interested in your take on that.
Wow that’s something to be scared about, let’s add it to the lists.
Why be surprised when people who are super-stressed out over all the misinformation about vaccines they have to process, and actually have the jab in the arm, experience symptoms like fatigue and nausea? I’d probably experience fatigue and nausea too, if I were convinced by the many conspiracy theories going around.
Would the vaccines be here anyway if there had been earlier approval? Intended for back-end of vaccine rollout eg.
Quite possibly not. I have learnt never to underestimate the stupidity of our federal government.
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).
And who is Australia?
Synecdoche Allan, synecdoche
by May he [Scovid] 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.
….. Moderna hadn’t yet applied.
to support the back-end of the vaccine rollout,
What a crock of shi///is Scovid, back-end? We’re not even in the middle of the Morri$sin/ Frewen strollout
A minor detail in Morrisonworld, Allan.
Morrison’s vacuity is as empty as his beliefs in a higher power dictating the rapture of being a PM without the joys of doing his job.
You may have to stop paying attention, Allan. It is apparently superfluous in the endlessly shape-shifting moral vacuum that is Morrison’s universe of deceit.
“We went with Pfizer mainly because of its capacity to deliver and it was not a new company,” secretary of the Health Department Brendan Murphy said in April.
In other words Pfizer’s lobbyists were more familiar and well-established faces?
It’s like “No one ever got fired for buying IBM” which was the dictum long ago when buying a (meaning one) computer was a major commitment not only for the mega$ but also for the risk the whole project could end in tears.
And then came the last census…