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.