Americans in states across the country started getting vaccinated with the Johnson & Johnson/Janssen Covid vaccine again yesterday, after regulators ended a suspension of the vaccine that had lasted almost two weeks. The FDA and the CDC decided to halt the use of the J&J vaccine on April 13 over concerns about a rare blood-clotting disorder that had been found in six people who had received it, one of whom had died. (AstraZeneca’s Covid vaccine, which is in wide use in the U.K. and Europe, has also been linked to blood clots). On Friday, ACIP, the CDC advisory panel on vaccines, after looking at all the data, concluded that the risks imposed by the vaccine were very low, and recommended that it be put back into general use, with a warning label attached.
Now, you might look at this story and assume that, as they say, “The system worked.” But it’d be more accurate to say that the system worked as it’s designed to work, and not as we might want it to work. While the initial decision to pause the vaccine was praised by many as evidence of the seriousness with which regulators were taking safety, that doesn’t mean the decision to extend the pause for almost two weeks represented a sensible balancing of costs and benefits. Instead, as medical ethicists Govind Persad and William Parker put it in The Washington Post last weekend, “slowing down vaccinations was a deadly mistake.” It was also, in some sense, a predictable one.
The decision to extend the pause was effectively made last week. The ACIP panel met a couple days after the suspension began, having had the chance to look at the available data. It could have decided then that the benefits of the vaccine outweighed the risks for all potential recipients, or, since all the people who had suffered the clotting disorder were women under the age of 50, it could have recommended administration of the vaccine come with age or gender restrictions until more data was available. Instead, it chose to kick the can down the road.
This was described at the time as the panel choosing to make no decision about whether the vaccine was safe. But as Dr. Nirav Shah, Maine’s CDC director, said at that first meeting, making no decision was a decision. While the U.S. has plentiful supplies of the Pfizer and Moderna mRNA vaccines, the J&J vaccine — which only requires one shot — has been very valuable in vaccinating people who might have a hard time returning to the same location three or four weeks later to get a shot, including homeless people, people who live in remote locations, and transient workers, as well as college students who may soon be going home from school. So you can’t just substitute Pfizer and Moderna shots for all J&J shots. What this means is that the decision to keep the vaccine pause in place amounted to a decision not to vaccinate lots of people who otherwise would have gotten vaccinated. Some of those people who did not get vaccinated have been or will be infected with Covid, and some of them will be hospitalized, and some will die. That was a concrete and undeniable consequence of the decision to extend the pause.
It’s also, though, a consequence that’s hard to see and easy for the public to ignore. The cost of vaccinating — people getting blood clots — is visible and quantifiable: we now know 15 people, all women, have come down with this clotting disorder after being vaccinated. (That’s out of 8 million people total who have received the vaccine.) The cost of not vaccinating — the unvaccinated people who are going to end up in the hospital and who, in some cases, will die — will essentially remain invisible, despite being all too real. We’ll never know exactly how many of those people there were, let alone ever know their names.
Erring on the side of caution, then, insulated regulators from the criticism they would have received had they resumed administering the vaccine after a few days and someone had suffered a serious blood clot. Precisely because of how visible that would have been, they would have been blamed for it in a way that they are not, for the most part, being blamed for the people who didn’t get the J&J vaccine over the past 10 days and who were infected with Covid as a result.
Beyond that, no matter how rigorous regulators try to be, they’re subject, like all of us, to cognitive biases. One of the most potent is the availability bias, which means that things that come immediately to mind (like people getting cerebral blood clots) have more influence on our decisionmaking than they otherwise would. The flipside of that is what you might call the unavailability — or invisibility — bias, and it’s just as potent: things you can’t see, and can’t document with 100% certainty, have less influence on our decisionmaking than they should. These things work together to push regulators, even if unconsciously, to overweight the risks of resuming vaccination and to underweight the risks of not doing it.
Now, in the grand scheme of things, the costs of this delay were not great. There may be some impact on people’s attitudes toward the J&J vaccine, but it’s not clear how large that impact will be, and there seems to have been no impact on people’s willingness to take the Pfizer and Moderna vaccines. But saying that the costs were not great is not the same as saying they were not important. At Friday’s meeting, the CDC’s Sara Oliver said that over the next 6 months, the J&J vaccine would be expected to result in 800–3500 fewer ICU admissions, and 600–1400 fewer deaths, while causing 26–45 cases of clotting. If you extrapolate from those numbers, they suggest that if the pause had ended 10 days earlier, somewhere between 33 and 75 lives would have been saved, at the cost of 1–2 cases of clotting.
Now that may be a overestimate. But the point is the same: the pause cost many more lives than it saved. That may have been a reasonable price to pay in order for regulators to be more sure that the vaccine was safe. But it’s important to recognize that a price was paid — and it wasn’t paid by the people who made the decision to pause the vaccine.