How did the British government approve the Pfizer/BioNTech vaccine so quickly, and should people be worried?
That’s the question being asked after Matt Hancock and Jacob Rees-Mogg falsely claimed Britain was only able to expedite the use of the vaccine thanks to Brexit (we are still, in the operation of our laws, institutions and businesses, EU members until the transition period ends on 31 January, and we have temporarily approved the vaccine under measures available to all EU states).
It’s a claim that neither Boris Johnson last night, nor Gavin Williamson this morning, were willing to support, with each finding different ways to avoid the question. Nonetheless, it has fuelled concerns about the speed of the process, including among Morning Callers, who sent more emails about this subject than I have ever received on a single topic, so I wanted to use today’s email to explain in more detail why the British government has done this and what the consequences are, while hopefully reassuring readers.
How has the Medicines and Healthcare Products Regulatory Agency (MHRA), the UK health regulatory body, been able to move so quickly? It has done so by conducting a rolling review of the Pfizer vaccine – by examining results as they come in, rather than waiting for the end of the trial.
First, it’s important to understand that the British people are not going to be guinea pigs for this vaccine ahead of anyone else in the world. The US will decide whether to approve the Pfizer vaccine on 10 December. The logistical challenges of cold chain storage and marshalling volunteers to inject people, and that the vaccine requires two doses, three weeks apart, mean that by the time the vaccine is approved in the US, almost nobody in the UK will have received a first dose, let alone a complete treatment. Indeed, by the time the EU gives its decision on 29 December on whether to authorise the vaccine, only a small number of people will have received it.
If there were any side-effects not picked up in trials, they would become apparent long after approval had been granted or denied in all three regulatory territories. We are not being used as guinea pigs, or as the first area in order for an American pharmaceuticals company to encourage a US-UK trade deal, or to boost Pfizer’s standing: UK approval, while meaning a couple of people will receive it a few weeks earlier, is not going to make much difference to the long-term prospects of this vaccine.
[see also: The race for a Covid-19 vaccine]
It’s true there are some risks involved, whether you are taking the vaccine in the UK, the US, the EU or anywhere else. The rollout of any new vaccine to large numbers of people always has the potential to reveal new risks. But the potential risks of any new vaccine that has passed initial tests and got to this stage in the UK’s regulatory process are significantly lower than the risks of coronavirus, particularly to the at-risk groups who will be the first to receive it.
Remember that this first vaccine rollout is only to those at the very greatest risk. The risks of not being inoculated if you are in an at-risk group, both from Covid-19 and the indirect costs of isolation and lockdown to your mental and physical health, far outstrip those of a novel vaccine.
And the biggest risk to all of us, given that some people cannot take vaccines, is that vaccination scepticism leads to large numbers refusing to take it, allowing coronavirus to keep spreading.
But that’s why it was not just highly unhelpful, but actively dangerous, for Hancock and Rees-Mogg to use the vaccine to advance a party political argument. No political party or proposition in the democratic world has ever recieved the level of support or buy-in you would need to achieve long-term eradication of a disease via vaccination. When vaccines become a partisan argument they lose support rather than gain them.
By trying to fold vaccines into an argument for Brexit, even if the Conservatives are winning over Leave voters, they are going to strengthen and deepen anti-vaccination sentiments among Remain voters. A slanging match with other European nations and the US about whose regulatory approach is best is a distraction the world doesn’t need – and one that can be avoided if ministers simply tell the truth and explain our process in a clear and lucid manner.