by Dawn Ford
On Monday, unless you work for Zoom, your stock prices likely soared with the news that Pfizer had got its Covid vaccine to a point that it would be seeking licensing, with a view to releasing vaccines for use before the end of the year.
And while I accept that not everyone supports vaccines, for a variety of reasons, I was a bit taken aback when a family friend, an asthmatic in her 70s, announced to my Mum that she would likely not have the vaccine because, “remember thalidomide”.
For those who don’t remember it, this was a drug given to pregnant women for the treatment of morning sickness in the late 1950s and early 1960s which, in some cases, caused significant birth defects. It caused a furore at the time and rightly so. But it wasn’t the first time risks had been taken in finding drug solutions to medical problems.
If we take ourselves back to the origins of vaccines, a chap called Jenner, noticed that milkmaids who’d had cowpox didn’t seem to get smallpox. So he took the radical step of infecting a volunteer with first cowpox and then smallpox. Happily for Jenner, the volunteer recovered and that was the first step on the journey of ridding the world from smallpox. A journey that took 179 years. Of course had his experiment not worked, he might have been hung for murder. Hardly an auspicious prospect for the would-be scientist to embark on a vaccine development career.
Of course vaccine development has changed beyond measure since Jenner’s early experimentation with a natural vaccine back in 1796. Jenner’s study sample was just 1 patient. Pfizer’s study sample in the current Covid trials has been something closer to 45,000. Jenner had no placebos, no blinds, no careful selection of trial patients, no adverse event reporting and almost certainly no informed consent process. And all of these safety measures are part of the reason why the process from getting a drug, of whatever kind from Phase 1 trials through to license for use, is usually a job of many years. So it is nothing short of remarkable that not only Pfizer has come so far, so fast, but that a number of companies have come so far, so fast – because Pfizer might be the first to declare but there are more than 40 different vaccine trials ongoing round the world, all in a race to find a solution to the current pandemic.
Excitingly, not all of these vaccine designers are trying to crack the Covid ‘nut’ in the same way. Some are following the more traditional path of using a disabled or attenuated version of the Covid virus (a version of the virus that has been made less virulent, which will provoke an immune response but will not result in a full blown infection). The Pfizer trial is using mRNA (messenger RNA), which is effectively a small piece of code which carries design instructions from the nucleus or brain of a cell to the protein building parts of the cell and these little manufacturing units create the biological weapon that counters a Covid infection and stops it in its tracks.
In the years before I was a lawyer, I was a geneticist. And when I went to university, the human genome project – another global scientific effort that was tasked with sequencing all the genes that make up a human – was about half way through. It took 13 years to sequence that first person. Now you can send off a saliva sample and in a fortnight know if you and Danny Dyer alike, are related to the Royal family. The idea, back when I started my BSc, that in a period of 9 months, we could design a genetic code based vaccine was just science fiction.
Now, is Pfizer’s new vaccine perfect? Of course not. There is no such thing. And while the Phase 3 trial results are showing a frankly astonishing 90% success rate, it has so far only been tested on a sample of the population and we don’t know if this current success rate will hold across the entire population. We don’t know how long the protection will last. Nor do we yet fully understand its side effects – and to be sure there will be some – if you look at the warnings on the average packet of paracetamol you’ll discover the possible outcomes include death. Not a big chance of death - in fact actually an incredibly small chance of death – but death all the same. And no doubt millions of people, every day, knock back a couple of paracetamol for a headache or some other pain and never give that a second thought. And that’s because paracetamol is no longer novel. It probably lurks in the medicine drawer of almost every home in the Western world. Now that doesn’t mean we shouldn’t ask questions about its risks; about its efficacy – but in the main we don’t because, well, everyone takes it don’t they?
And that’s part of the problem my Mum’s friend has. It’s all a bit new and a bit scary. And well, medicine hasn’t always got it right in the past, have they? No. They have not. But crucially no other profession has omniscience or infallibility either. We learn through error. We get better by understanding what we got wrong last time. And to that extent thalidomide is relevant. As is every other drug that has not been as effective as expected, or had unwanted and sometimes very serious unintended consequences, because we learned from that history. That’s why there are specific protocols for what to do during a trial if a trial patient falls pregnant. And it’s why we continue to monitor those initial volunteer patients who take part in trials, long after the drug has moved into use. We know now that these steps are really important protections to ensure that drugs only reach us, the general public, if they’re reasonably useful and have tolerable side effects.
So what if it’s new? Everything was new once. Cars were once considered so dangerous that a man had to walk in front of it waving a flag to warn pedestrians the car was coming. Mobile phones were going to fry your brain. We might now consider if we can drive less to help the environment, or use our mobile phones less for our mental health but no-one would reasonably suggest that either or both should be avoided at all costs.
This week is not the time for fear – Covid has brought enough of that. This week, to me, is a time for wonder. Wonder at how far science has come. Astonishment that so many drug trials have come so far so fast. Delight that when unified in the fight against a common problem, the brightest and best of the scientific community stepped forward and accepted the challenge. What a cause for optimism.
This is by no means the beginning of the end; although it might possibly be the end of the beginning. SARS viruses, of which Covid is one, have jumped the species divide before – and it will almost certainly happen again. Already in Denmark, there is emerging evidence that Covid has jumped from humans into mink, mutated and jumped back into humans. So if you think this drug development is fast – and let’s be clear, it is – it’s not nearly as fast or as tricksy as the virus it’s fighting. Viruses are expert mutators. That’s part of the reason why we have an annual flu vaccination program, because H1N1, the influenza virus and cause of the last global pandemic at the end of the First World War, like all other viruses, is a shape shifter; a chameleon; a wolf in sheep’s clothing. We need to be fast; because the virus will always be faster.
So by all means, observe reasonable caution. Ask questions. Read the clinical trial information for yourself – it’s easily found. Be informed. But don’t fear something just because it’s new. And don’t think that fast has meant cutting corners. Just as we all learned to use Zoom almost instantaneously at the start of lockdown – our scientists have learned what can be achieved in the face of necessity and when everyone asks how we remove every barrier to success. And that is a lesson every business is keen to learn from.
Author: Dawn Ford - Volt Legal Counsel