Despite Australian government assurances, there are serious questions hanging over the nation’s readiness to begin a national COVID-19 vaccination program, yet these questions have nothing to do with the failure of the UQ vaccine.
The UQ vaccine – which was undergoing a Phase I trial for safety – wasn’t going to be ready for population-wide use until the end of 2021 at the earliest.
What went wrong? The experimental coronavirus vaccine used a harmless HIV protein as an effective clamping tool on the famed coronavirus spike.
The trial was abandoned because some participants generated HIV antibodies that would compromise regular HIV screening – and fixing the vaccine would have set the project back another year.
This isn’t a disaster for UQ. The platform was clever and all that hard work is bound to lead to other vaccines – possibly even one for HIV.
No worries, we weren’t betting the farm on UQ anyway
A statement released by Health Minister Greg Hunt’s office on Friday reassured the nation the federal government had “strong confidence” that a COVID-19 vaccine would “likely” to be available to Australians from as early as next March.
The government said “we can achieve our goal of providing a vaccine to all Australians who seek to be vaccinated before the end of 2021.”
To this end, Australia has secured an additional 20 million doses of the “promising” Oxford/AstraZeneca COVID-19 vaccine, “strengthening Australia’s position for whole-of-population vaccination.”
Minister Hunt said this will mean a total delivery of 53.8 million AstraZeneca vaccine doses in 2021, “covering the whole of population requirements.”
The extra 20 million doses of the AstraZeneca vaccine would be produced within Australia by CSL.
In addition, a further 11 million doses of the Novavax vaccine would be purchased, bringing the total for this vaccine to 51 million.
Sounds great, but then there’s the fine print: “This provides an additional whole-of-population vaccine for Australia if proven safe and effective.”
And this is where the story gets complex.
Neither vaccine under order is ready to go
The Oxford/AstraZeneca vaccine is indeed “promising” – and recent data indicate its safety margin is “convincing.”
The problems are these: the extent to which the vaccine reliably works, especially in older people, remains unclear; the range of efficacy data from three trials is significant; and the manner in which the company managed disclosure of a mistake in one of the trials has led to a feeling the company can’t be entirely trusted.
As The New York Times put it last month: “The odds of regulators in the United States and elsewhere quickly authorizing the emergency use of the AstraZeneca vaccine are declining.”
Just prior to that report, it was all good news.
Oxford/AstraZeneca had produced a vaccine with an efficacy of up to 90 per cent. Better still it could be had “for the price of a cup of coffee”.
Then it was revealed that the overall efficacy of the vaccine was 70.4 per cent. So … what did these numbers mean?
In effect, there were three trials. Two groups – one in the UK, one in Brazil – were given two standard doses, a month apart, with okay results.
The UK trial had an estimated 60.3 per cent efficacy; the Brazil trial had an estimated efficacy of 64.2 per cent. Averaged out, the combined efficacy was 62.1 per cent.
In a third trial of about 3000 people in the UK, participants were accidentally given a half-strength dose in the first injection.
When it became clear that side effects such fatigue and headaches were milder than expected, the mistake was revealed.
On the upside, when the participants received the second full-strength injection, 90 per cent of the group were protected against the virus. However, none of the participants were older than 55.
Overall it was a happy mistake.
Potentially, the vaccine could work as well as those from Pfizer and Moderna. Oxford/AstraZeneca simply had to conduct a bigger trial with the half-strength/full-strength combo. And this time, include older people.
“They do need to do more work on that, with a bigger sample, to see if the results are genuine,” said Deakin University epidemiology chair Catherine Bennett.
“There was such a striking difference in the group that received the half dose, that it’s worth pursuing… to establish if that’s the right dose to go with. And they will pursue that,” Professor Bennett said.
But with the company having seriously muddied the water in the mean time, Australians deserve a clearer understanding of the vaccine’s reliability before proceeding taking it in the arm en mass.
For further detail about the difficulties of mixing these results, see this piece in The Conversation.
What about the Novavax vaccine?
The Novavax story has been called a fairy tale.
The company is a small, innovative vaccine-maker based in Maryland that has never actually brought a vaccine to market. Just 18 months ago it was thought to be on the brink of collapse.
When the pandemic took hold, it quickly emerged with a vaccine made from moth cells that appeared to knock out the the coronavirus spike protein.
It reportedly “outshone major competitors on key measures in monkey and early human tests.”
And although it received a US$2 billion grant from Donald Trump’s Operation Warp Speed, allowing it to compete with big companies such as Pfizer and Moderna, it relies on contract manufactures to meet its target of a billion doses – including those 51 million on order from Australia.
The real problem is this: Novavax has twice delayed its Phase III trial that is meant to prove efficacy on a big scale. It hopes to start this trial in a matter of weeks.
Greg Hunt and Scott Morrison are bound to have their fingers crossed.
They have a few other options, including a “purchasing agreement” for 10 million doses of the Pfizer vaccine being rolled out in Britain.
Pfizer, though, last week, said it needed to cut its projected production in half.
It’s all proved trickier than they thought.
Another coronavirus vaccine has fallen by the wayside, with big pharmas Sanofi and GlaxoSmithKline delaying their candidate jab to late next year.
The companies said early-stage trials showed the vaccine produced an “insufficient” immune response in older adults, so they would have to refine the product so it protected people of all ages.
Meanwhile AstraZeneca will begin testing its vaccine in combination with Russia’s Sputnik V shot in a bid to boost the efficacy of the Oxford-developed vaccine.