The J&J Vaccine Is Not a Tainted Cantaloupe

Our regulators are not fools. But they have a peculiar sense of responsibility that leads them to adopt a fraidy-cat level of caution.

I am one of the nearly 7 million Americans with the Johnson & Johnson vaccine percolating through my tissue at this very moment. It feels good. The sensation of rising immunity to COVID-19 would almost certainly still feel good if I were a woman between the ages of 18 and 48, like all six of the vaccine recipients who later suffered from blood clots. The clots, which might or might not be related to the vaccine, can kill you; one of the six patients died. If you treat the clots the wrong way, the treatment can kill, too—which is why the CDC and FDA paused J&J vaccination yesterday morning, and left the vaccine in my body a limited-edition commodity, like a final gulp of Coke Classic.

Let’s say the connection to the clots is confirmed and the numbers hold. If COVID-19 shots are seasonal, like the flu shot, and you have to get one every year, then your COVID-19 shot will on average kill you if you live to be 7 million years old, which by the way is a serious comorbidity in itself. Government health authorities have to think about low-probability events, and they sometimes withhold drugs from mass distribution because of rare adverse effects. But the J&J vaccine should be redeployed to the front lines of the COVID-19 war as soon as possible, and it should not have been removed from service in the first place.

The White House COVID czar, Jeff Zients, explained yesterday that the other vaccines make up the great majority of those administered, and that the absence of a J&J option will not pull the country off its target vaccination pace. In his announcement he reiterated the administration’s promise to “lead with science, tell the truth, and give Americans the facts as we know them.”

Americans, however, have no option but to accept the FDA’s interpretation of those facts, and its rationale for its strange paternalism. Government agencies are good at dealing with large numbers that ordinary people do not understand. These numbers are large and easy to understand. A one-in-7 million risk is about the chance of being struck by lightning in a given year. Looking only at the possible at-risk group of women under 50: Perhaps 1 million received the J&J shot and one died—that’s the chance of death from overdosing on Tylenol in a given year. Can ordinary people not make up their minds about this risk? Would you accept an increase in your risk of an adverse event, equivalent to the odds of a lightning strike, in exchange for vaccination today and a speedier return to something resembling pre-pandemic life? If you had posed the question to me this way when I reached the vaccination site, I would have grabbed the syringe and plunged it into my right deltoid with gusto. Speed matters, because I do not want to wait any longer than necessary for relief from a disease that I could pass on to others.

I was glad to hear that the U.S. can maintain a steady pace of vaccination without the J&J doses. But if they are not necessary, why do we have them? Meeting the administration’s target matters much less than vaccinating the population as quickly as possible. We should aim to clear the shelves of vaccines every single day, J&J vials included, or else send them to the many other countries that are desperate for them.

Our regulators are not fools. The kind of cost-benefit calculation above is within their ability to assess, if it is within mine. But they have a peculiar sense of responsibility that leads them to adopt a fraidy-cat level of caution (an “abundance of caution,” said the press release) that no normal person should want in her daily life. If you are unwilling to accept one-in-7 million odds of death, you should be unwilling to drive six miles to the vaccination site. (I drove three hours.) Forget other thrill-seeking activities, such as eating mixed nuts without an EpiPen nearby, or going for a bike ride.

One might argue that vaccines must be held to the highest standards, so no one doubts that they are safe. Unlike other medicines, they are administered to otherwise healthy individuals. First do no harm. This logic may be what motivated the regulators to pause the vaccine: If you make the approval process look rigid, even at the expense of a few net deaths, more people will have confidence in that process. But rather than shield people from risks, in hopes of winning their confidence, why not inform them of the risks in comprehensible ways, and win their confidence through honesty? Do not hide the risks. Enumerate and explain them. The FDA could issue an advisory for a clotting issue and note that it is as rare as a lightning strike, and say that the vaccine is still in use because getting it is safer than not getting it. Pausing all J&J doses, to all ages and sexes, will make people think of tainted cantaloupe or pickup trucks recalled for faulty brakes; the stigma may never disappear.

Right now there are no “otherwise healthy individuals.” Even those of us who have escaped infection are sick of being cooped up, held hostage to our Netflix queues, and starved of friendship, work, and leisure. And I expect that the pause in J&J distribution, however brief, will make many people doubt vaccines irrationally, rather than thank their regulatory overlords for averting a lightning strike. I would rather die of a blood clot, ideally 7,000,000 years from now, than spend another day in quarantine.