Halleluiah. Praise Dan Andrews. Praise Scott Morrison. Praise Oxford University and the University of Queensland because we are going to have a COVID-19 vaccine by the end of the year and everyone is going to be able to get their lives back to normal. In case you hadn’t noticed, I was being sarcastic.
The rosy, triumphant spin that the politicians give you is a big old pile of bull****. The chances of it all working the way they want it to is a million to one. Stay with me and I’ll tell you why.
The first reason is because it is bloody difficult. Not running a marathon difficult but accomplishing something that has never been done before difficult. Think Hillary or Armstrong not your Sunday afternoon fun runner. Let’s face it, corona viruses have been around as long as humans. Afterall, the common cold is a corona virus and we haven’t found a vaccine for that but the fact that a cold is not much more than an annoyance means that the desire has not outweighed the necessity. SARS and MERS are also corona viruses and we started trying to develop a vaccine for them but luckily, the problems seemed to peter out by themselves. Unfortunately, when they did, so did the necessity for a vaccine.
When it comes to COVID-19, even with an abundance of necessity the task is monumental. I don’t think that our politicians realise that there is an extremely high chance that the first few attempts won’t work. It’s really important that we don’t look at these as failures though. Every attempt is a learning experience and one step further to the result we so desperately need. I have no doubt there will eventually be a safe effective vaccine, just don’t expect it straight away.
Part of developing a vaccine is the trial process. With any drug or treatment there are a number of phases that needed to be completed in order for a new treatment to be approved. First is the pre-clinical work. This normally involves having a hypothesis. This hypothesis needs to be tested which normally happens by benchtop research or during animal models. I’ll use the example of a trial I know quite well, HSCT for Multiple Sclerosis, very similar to my HSCT that was for CIDP. They started with animal models and guess what. The first experiments failed. This was due to the selection criteria and once this was resolved, the experiment succeeded.
After this we can move to phase one, which is where we test a small number of people (Anywhere from 5 to 80) normally one at a time to gage safety. Phase two is a larger cohort and starts to look at the efficacy of the treatment. If both these trials are successful then a phase three trial would be conducted scrutinising both safety and efficacy. If that is successful, we have a new treatment that can be marketed to the people. In the case of HSCT for MS, this process took 20 years.
What worries me is that a process that normally takes years is now taking months and that means cutting corners. When I was a participant it the phase two trial of HSCT for CIDP I had follow up studies every year for five years. There is simply no way to test the safety and efficacy of a treatment over time, other than to test it over time. I understand that it is possible to speed up the clinical trial process by increasing sample size, increasing staff to help with lab work and processing results but all the money and resources in the world cannot speed up time. We’ll effectively be finishing these trials on approved vaccines and if we find any nasty surprises we’ll be in real trouble.
Assuming we do tick all the boxes, we then have to worry about mass producing the thing. If we want to get any vaccine to everyone in the world, we need to make at least 7.5 billion doses. We can’t even get fresh drinking water to that many people. In Australia we will need at least 25 million doses and don’t think that we can administer this easily. We still don’t even have antibiotics available to every Australian community.
We also have to acknowledge that we’re not just baking bread. Developing a vaccine is difficult and upscaling manufacturing to meet demand is even harder, then there are logistical and distribution issues to consider.
Next time I’ll be talking about other issues of vaccines.
Until then,
Stay well
As I finished writing this the AstraZeneca vaccine, developed by Oxford University has had their phase 3 trial put on hold because of safety concerns. This may just be a small bump in the road, it may stop the vaccine dead in its tracks. It just goes to show that the road is long and difficult but we will get there.
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