It takes a big piece of news to knock the Biden/Trump stand-off from the front pages but that is what the announcement by Pfizer and BioNTech concerning a possible Coronavirus vaccine accomplished on 9 November. Here is one of many summaries, from the BBC’s website.
Few things get more media attention than medical breakthroughs. Not all have lived up to their promises. So, is this really as good news as it appears?
Cautiously, yes it is, in the opinion of Professor Jon Crowcroft of the University of Cambridge. (His field is Computer Science but he has been working closely with many experts on a variety of aspects of the pandemic.) There are several ways in which the basic approach to a vaccine could be based, perhaps like deciding if you’re going to fight a fire with water, foam or gas. The one the Pfizer/BioNTech team took was the RNA method, which prompts the body’s immune system to develop appropriate antibodies and T-cells. Other teams, including the one at the University of Oxford, have followed a similar path (on 4 November 2020, The Lancet reported that 45 candidate Covid-19 vaccines are in clinical trials, ten of which have reached the crucial phase 3 stage). “The good news here,” he told Penny Post, “is that if one of these RNA methods works then, assuming equally good protocols, they all should. Having several but subtly different vaccines is good because their effectiveness and side-effects can be empirically compared. Obviously, more than one supplier also reduces supply-chain vulnerabilities and, of course, the costs.”
This has all happened very quickly. Tomorrow’s Pharmacist (admittedly back in 2015) suggested that the passage of a drug from lab to shelf can take up to 12 years: this has all happened in about nine months. Have any corners been cut here? “It would seem not,” Professor Crowcroft replied. “There are three basis stages to creating a marketable drug. First you have to asses what approach you’ll take and whether any new tech needs to be developed. Then you have to test it. WHO protocols demand a number of phases, phase three being where we are with this one. That can’t be speeded up as it involves seeing if it works well, and without unintended consequences, on a sufficiently large and representative sample. To use your analogy of fire-fighting, that means finding or creating a range of different fires in different circumstances and with different materials and being sure that the interaction of the conditions and the cure provided the desired result.”
Crucially, the timescale is also dependant on how long the fire, or the disease, might take to develop before it becomes evident. It’s known that Coronavirus can take the best part of two weeks to incubate. Humans are vary in their reaction to the disease, and to any cures. Different people respond to drugs, medicinal or otherwise, in very different ways. It’s impossible to predict every outcome in every case but if all the protocols have been followed – as it appears they have in this case – the risks diminish almost exponentially.
In the final analysis, any assessment comes down to a question of managing the risk of using the drug against not developing it quickly enough, or at all. “The only recent case I’m aware of where the testing process did cut corners was with Ebola,” Professor Crowcroft said. “The disease was, however, almost invariably fatal, and in a very unpleasant way, so the WHO decided that a high level of risk of contra-indications was acceptable.” The fact that the WHO did not loosen its protocols with regard to Coronavirus is perhaps therefore encouraging: it’s nasty, it’s clever and it’s infectious but most of us don’t die from it. (As other research is suggesting, some of us also have some built-in immunity which can mitigate its symptoms and morbidity rates.)
The third aspect is the approval – by the Food & Drug Administration in the US, NICE in the UK and by a host of other bodies worldwide. For obvious reasons, any Coronavirus vaccine is likely to get to the top of the pile. “This is not just a bureaucratic or political process,” Professor Crowcroft pointed out. “The regulators can, and often do, state that insufficient testing has been done on, say, particular age groups or people with particular pre-conditions and, as a result, limit the drug’s range of prescription. To go back to your firefighters, they might say ‘you haven’t provided enough evidence that this method is safe where there are large quantities of petrol, or high winds, so we won’t recommend your product for that. Do some more verified research and we’ll have another look at it.'”
No responsible commentator has yet suggested that this, or other similar solutions, will be flawless, immediate or permanent. (On the last point, a year’s immunity seems the most we can hope for, but this puts it in line with flu vaccines.) There are still regulatory hurdles to cross as well as the logistical problems of scaling it up to the required levels. In the mean time, the current policies of social-distancing, face-covering and test and trace remain as important as ever. None the less, it seems like a major step forward. “It’s not perhaps that surprising,” Professor Crowcroft concluded. “For obvious reasons, worldwide some of the finest minds in a range of disciplines have been working on this flat-out. The first stage was speeded up by necessity and hopefully the third, approval, will be as well. The second, testing, stage, seems to have been done as quickly but also as thoroughly as the timescales of the virus’ infection cycle permitted.”
Coronavirus is a fire that has ripped through societies round the world. A vaccine has long been seen as the magic bucket of water to extinguish it. Whether this announcement from Pfizer and BioNTech proves to be the universal retardant we have all hoped for remains to be seen. The most important decision will, perhaps, be a global one: assuming it is all its proponents claim, will this or other similar vaccines be available for everyone, in every continent, and at a price that all health systems can afford? The pandemic has clearly shown how interconnected our societies are. A global approach is essential, as it was with diseases such as smallpox. All of this brings us back to the Biden/Trump stand-off. Given the latter’s distain for international agencies and international co-operation, today’s vaccine announcement has made the result of the US election even more important – and even more welcome.
Brian Quinn
