Based on what we know right now, the math still strongly favors using this vaccine. Unfortunately, the FDA’s action has probably made people less likely to take it, or any coronavirus vaccine, even if regulators ultimately pronounce it safe. Even more unfortunately, this is a pattern: When faced with a difficult decision, the FDA almost always chooses the more restrictive option.
The defense of this institutional conservatism is generally that it has prevented the approval of drugs with awful side effects, such as thalidomide. That’s true. But economist Alex Tabarrok points out that excess caution has an equally real price, which he calls “the invisible graveyard.” It’s full of people who died waiting for the FDA to be extra sure about a good treatment.
Only in a global pandemic, when we are all watching the deaths pile up, do we see the grim outline of all those invisible tombstones we’ve been paying for. And having seen them, we need to do more than just shout at the FDA about this one case; we need to decide right now whether we’re willing to pay such costs — and if not, how we’re going to stop overcautious regulators from digging more graves.