Tegan Taylor: Hello, this is Coronacast, a daily podcast all about the coronavirus. I’m health reporter Tegan Taylor.
Norman Swan: And I’m physician and journalist Dr Norman Swan. It’s Friday, 12 March, 2021.
Tegan Taylor: And Norman, one thing we keep hearing about the vaccines is that they should been developed in record time, at breakneck speed, and all of these sorts of really fast words, and you’ve got something to say about this; they actually haven’t been developed as quickly as people think.
Norman Swan: No, and I hear doctors saying it. I’ve come across specialists saying, ‘Oh, I’m not having this because it’s been developed too quickly and we just don’t know.’ And it shows a fundamental misunderstanding here, and it frightens the public. Every time somebody stands up, a minister or somebody stands up and says, 'Isn’t it fantastic, this miracle, that we’ve developed these in such record time, it’s a miracle of modern science,’ it actually scares people because they think it’s too quick.
So it’s not too quick at all. So let’s just dissect this whole vaccine development thing. So anybody listening to Coronacast who has had a medication by prescription from their doctor, that medication has been approved on the basis of a randomised phase 3 trial. That’s how things get approved, randomised phase 3 trials. So whether you are on cancer care or antibiotics or other drugs for diabetes or what have you, or heart disease, they have been approved on a randomised controlled trial, a phase 3 trial which shows efficacy.
So if you actually think about where it has been approved, the point to which the vaccines got is the point at which vaccines and drugs are normally approved. So, where does the idea of rushing come from?
Well, people think that these vaccines have been developed in the same year, in this past year, which in fact is not true. We just did a little bit of history. Two or three years ago an organisation called the…I think it’s called the Coalition for Epidemic Preparedness and Innovation…
Tegan Taylor: CEPI, yes.
Norman Swan: Had effectively a competition. The competition was come up with a vaccine technology platform that could develop a vaccine to a new virus within 16 weeks.
Tegan Taylor: It was off the back of the Ebola outbreaks in Africa where they felt like they were just chasing their tails and they needed to be on the front foot next time.
Norman Swan: That’s right, they do another pandemic was coming. So five groups or five technologies won it. There was the University of Queensland technology and the mRNA technology and a couple of other technologies won it, and they won it a while ago.
What happened was that these technology platforms were shovel-ready in January, so much so that when Eddie Holmes at Sydney University released the genome worldwide, companies like Moderna were onto it straight away and within a matter of weeks had already designed, effectively, the first version of their vaccine. It’s true that some of these vaccines hadn’t been fully studied in humans but they were well-developed platforms, they still had to go through phase 1 studies. They were pre-existing platforms that were designed to produce vaccines quickly, that’s why they won the prize.
So then it comes to the trials themselves. Have we short-circuited the trials? Well, the one bit of the trial that has been a bit short-circuited is the phase 2 studies where they spent a lot of time looking at doses, that’s probably one reason why the Astra vaccine got in a bit of trouble, but effectively they went to phase 3 being pretty sure of what dose they needed in most of the vaccines.
A phase 3 study, there are lots of examples of drugs, forget vaccines, which failed to even recruit enough people that the trial is ever done. There is a high failure rate in phase 3 studies, just to recruit enough patients. And in vaccine studies they are notorious for taking years sometimes to recruit enough patients to be able to do the phase 3 study. Because there were millions of people with COVID-19, they were able to recruit 40,000 people for each trial incredibly quickly, and because there was so much virus around they got infected very quickly and so you got to what’s called the endpoint very, very fast, unprecedentedly fast, not through any short-circuit, but it’s just all the other stuff you would normally wait for years to because it all happens slowly, happened quickly.
Tegan Taylor: Right, so the years and years that we usually wait for vaccines isn’t the science that we are waiting for often, it’s just the prevalence of whatever the disease is.
Norman Swan: It’s the pure pragmatic element of doing a trial when there’s not much virus around and you’re waiting for 200, 300 people to be infected against placebo to see whether or not it’s protective. That’s simply a waiting game. We didn’t have to wait. People unfortunately, tragically, were there and they got infected incredibly quickly and you got a result very quickly. So these vaccines have actually not been developed as quickly as you think, it comes to the same point. So if you are feeling uncomfortable about these vaccines getting approved on phase 3, you should feel uncomfortable about any drug you’ve ever taken because that’s what happens.
But the other thing about these vaccines, which has never happened before, it has never happened before that they have been approved with tens of millions of people having had the vaccine, at least in the Australian context, tens of millions had already had it in the real world with no new safety signals emerging. So in terms of safety and effectiveness, thanks to the Israeli data and the British data, we are confident that they work in the real world and that they are not dangerous, at least in the short to medium term. Long-term we have to wait and see but there is a very good track record in vaccines of not having problems in the long-term. So this whole thing about a rush is a mirage.
Tegan Taylor: So you’re saying there is actually more evidence for Covid vaccines that have been approved in Australia than there has been for many, many other drugs and vaccines that we have had approved in the past.
Norman Swan: 100%, so to speak. And speaking of 100%…
Tegan Taylor: Yes, let’s bust some more health communication furphies, Norman…
Norman Swan: Dragging these things down into the dirt.
Tegan Taylor: There has been a published paper in the British Medical Journal about how the B117 variant, the so-called UK variant, how deadly it is compared to the original Wuhan strain of coronavirus. And some of the headlines reporting on this study have said that it’s up to 100% more deadly than the original strain of coronavirus, which is a bit misleading, Norman.
Norman Swan: It is misleading. When you look at this study…and I’ll just try and be brief about this because it’s complex statistics…is that on the balance of probabilities, and we spoke about this the other day where somebody was picking me up and talking about averages, it’s a probabilistic thing. So on looking at this study which compared large numbers of people being infected with the old virus and the chances of dying, with the B117, the new virus, and what were their chances of dying, the probability was…the most likely probability from the study, nothing is certain, is that it’s a 64% increase in dying, which is still significant. It means that compared to the old virus where 2.5 people per 1,000 people detected died, it went up to 4.1 people per 1,000. So, it’s not good but it’s not 100%.
Where they get the 100% from is called the confidence interval, so I don’t want to get too complicated there, but they are really about describing how accurately you can be or how sure you can be that it was 64%. And the confidence intervals were really tight on this one. So, a high degree of confidence that it is 64%, not 100%.
Tegan Taylor: And it’s worth mentioning that even with the B117 variant, which does seem to be significantly more deadly, that’s in an unvaccinated population, and we do know that, unlike some of the variants going around, the vaccines that we’ve got are actually very effective at protecting against the B117 variant.
Norman Swan: In fact they bring the death rate down to zero.
So Tegan, it’s Friday.
