by Tom Chivers
Thursday, 28
October 2021
Debate
11:01

Red tape will cause more Covid deaths

Why can't western countries cooperate more on vaccines?
by Tom Chivers
Credit: Getty

Earlier this week, the FDA announced that it has approved a low dose of the Pfizer vaccine for children aged five to 11. The UK, meanwhile, appears to still be mulling over the decision: the Medicines and Healthcare Products Regulatory Agency (MHRA) has said that while 12- to 15-year-olds can use it, it’s still conducting a review into under-12s.

In the grand scheme of things, the stakes here are not particularly high: the delay probably won’t lead to actual deaths. But there was a point during the pandemic when the stakes were high and delays in regulatory approval did cost lives.

The Pfizer vaccine, the first Covid jab to enter widespread use, was approved in the UK by the MHRA on 2 December 2020 and the EU on 21 December. The AstraZeneca vaccine was approved by the UK on 30 December. But in the US, the Pfizer vaccine was only formally approved in October 2021 (although it was granted emergency use authorisation on 11 December 2020). Meanwhile, the US has never approved the AZ vaccine, only finding it “suitable for export” to India and other desperately-in-need countries — in August this year.

Looking back now, the difference between 2 December, 9 December and 21 December doesn’t feel that much of an issue. But back then, with the second wave in full spate and 500-odd people dying every day in the UK alone, it really was. In the first nine days of the US vaccination programme, about 1.5 million people were vaccinated. At that point, there were about 650 new cases per million people per day in the country.

If you naively multiply those numbers together, you get about 1,000 people who got the disease while unvaccinated who wouldn’t have if the US had approved the vaccine on the same day as the UK did. Given an infection fatality rate (IFR) of about 1% (which is probably about right for the time), that means about 10 people would have died who otherwise might not have, which sounds bad enough — but actually it’s worse than that, since the first people vaccinated would all have been elderly or vulnerable. The IFR for people over 80 was somewhere around 7.5%, according to this study. So, given that the vaccines are imperfect, probably somewhere around 70 people died. That may not sound like a huge figure, but considering that these lives were lost to a stupid regulatory delay, it is.

The EU’s longer delay would have cost commensurately more lives, and the US’s bizarre months-long refusal to either approve or give away the AZ jab was even worse.

Americans, Europeans and British people are not significantly different, biologically speaking, and our medical standards are pretty similar. The EMA and FDA have even agreed that their regulatory approvals are basically the same, and presumably the MHRA has not diverged all that much in the 20 months since we formally Brexited.

The next time a pandemic comes around, this sort of regulatory delay will kill people, again. Might it be worth setting up a system between highly developed Western countries that says “If a drug or vaccine is approved in country A, it can be treated as being given emergency approval in country B, so that we can start getting it into arms more quickly”? The likelihood that the delay saves more lives than it costs, certainly in cases where a pandemic is raging around the world, is vanishingly small.

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  • Having worked in the pharmaceutical industry, what struck me was the mindset of those in regulatory positions. There are many very intelligent people, but with the life outlook of a traffic warden on steroids. The system, the process to be followed, these had the status of holy writ – I use the comparison very deliberately. Slavish interpretation of guidelines without ever seeing the bigger picture, unable to think for oneself, to make cost-benefit decisions, or even understanding that such decisions exist in the real world. This applied both to people within the industry, and within the quangocracy/regulatory arms of the governments. It is true that there have been safety concerns of drugs in the past, but these will never completely go away – any novel activity has unforseen and unforeseeable risks. However the current approach simply creates hugely expensive jobs for pen pushers – next time you hear someone complaining about the cost of drugs and the greed of big pharma, remind them that we (and our elected politicians) created this impersonal machine by belief in regulation and procedures as a substitute for genuine scientific evaluation. After 1000 years I still don’t see any likelihood of the various Christian churches reuniting because of their often petty and obscurantist doctrinal differences, and similarly I don’t see any chance of easy alignment of pharmaceutical regulation.

  • Dr Thomas Sowell was a Marxist until he started to work in one of the US government agencies and it became clear that the aim of the agency was not to do what was best for the country but how best to preserve the agency and agency jobs.
    That ultimately is the aim of any bureaucracy and that is why they will fiercely resist any suggestion that another agency’s tests should automatically be accepted, and the politicians who rely on bureaucratic votes will support them for the most part. So don’t look for a sensible reform to emerge in a hurry.

  • Brilliant piece of clear concise, logical writing, please can someone publish this very very widely.

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