What COVID Taught Us, and What We Ignored

Every so often the industry gets proof that it can move faster than it says it can. COVID was the largest such proof in memory.

Under emergency pressure, a lot of things normally described as fixed turned out to be negotiable. Reviews moved faster. Inspections went remote. Requirements around filings and labeling that had been treated as immovable were suddenly open to flexibility. For a stretch, the machinery ran at a speed most of us had been told was impossible, and for the most part, it worked.

What I have thought about since is not that the system bent. It is what we did with the evidence afterward. We ran an enormous, unplanned experiment in how much of the usual process is truly necessary, and then we mostly threw the results away. Some of the changes that worked were reverted the moment the emergency was declared over. Others that carried real, if less visible, costs we leaned on heavily without ever really examining, and we are paying for some of those now. What we never did was the honest work of sorting one from the other. There was a snap-back reflex, and not much else.

Two examples have stayed with me, because they point in opposite directions.

A good change we gave back

During the emergency, Moderna, where I was at the time, was allowed to run a single global presentation for its COVID vaccine: an English-language label with translations available electronically, in place of the usual country-specific packaging, on the commitment that we would revert once the emergency ended.

The supply chain implications of that were enormous. Instead of managing a distinct SKU for every market, we had two, one for the US and one for the rest of the world. Two things to make, plan, forecast, and hold, rather than dozens.

And it did more than simplify inventory. It gave us flexibility in where product could go. Country-specific packaging commits inventory to a market the moment it is labeled. If demand shifts, that product is difficult to redirect, and you end up with supply stranded in one country while another goes short. A single global presentation meant we could send product where it was needed, when it was needed, instead of letting the packaging decide for us. In the middle of a global shortage, that was not a convenience. It was the difference between getting doses to people and watching them sit in the wrong place.

Then, as agreed, it reverted. The SKU count multiplied again, the inventory complexity came back, and the distribution flexibility went away. Not because anyone had shown it caused harm, and not because a better system replaced it, but because the arrangement was always built to end. The experiment produced a clear result, that a simpler global labeling approach could work at scale, and the result was filed away the moment it was no longer forced on us.

A risky change we did not look at hard enough

The other example points the other way. To keep oversight going when travel stopped, inspections went remote. Records reviewed over video, documents shared electronically, the auditor never on the floor. At the time it was framed as a reasonable accommodation, and given the constraints, it was.

I have come to think it was also a mistake we have not reckoned with. There is a great deal you can see in person that does not come through a screen. The state of a facility, the body language in a room, the thing an operator does when they think no one is watching, the document someone would rather not pull up. A remote audit sees what it is shown. An on-site audit sees what is there. Those are not the same, and the gap between them is exactly where problems hide.

I do not think it is a coincidence that we are now seeing a wave of Official Action Indicated outcomes and warning letters as inspections have returned to the floor. I cannot prove the connection, and I would not try to put a number on it. But it is hard not to connect the two. For a couple of years, sites could keep things out of view that an inspector standing in the room would have caught, and discipline has a way of slipping when the oversight loosens. Some of what is surfacing now looks like the bill for that arriving late.

The point is not that remote inspection is always wrong. In the middle of a pandemic it was a defensible call. The point is that we leaned on it heavily, then went back to on-site without ever really asking what it had cost us, the same way we gave back the labeling flexibility without asking what it had been worth. In both cases the emergency made the decision, and when the emergency passed, reflex made the next one.

The point

That is the part I keep coming back to. COVID handed us a rare thing: a real-world test of which parts of the process are essential and which are habit. We had the data. What we did not do was read it. We reverted the changes that had proven useful and normalized the ones that carried hidden risk, and we did both largely on autopilot, because reverting to the familiar always feels safer than deciding on purpose.

It is easy to lay that at the regulators' feet, and some of it belongs there. But industry is at least as conservative. Given the choice between a validated process we know and a better one we would have to defend, most of us choose the one we can defend, every time. The inertia is shared, and it is not irrational. It is just expensive in a way that never shows up on a single project, only across years of them.

So the question the pandemic left me with is not really about COVID. It is about how an industry this important actually moves forward, if it takes an emergency to loosen anything and a reflex to tighten it back the moment the emergency ends. We proved we can work differently. We just have not shown that we can decide to.