Fauci won't guarantee that J&J vaccine will ever return to the market after "pause"

I’m torn between thinking this is a bad answer and that it’s the only answer he could responsibly give.

Which is pretty par for the course on public-health guidance since the start of the pandemic, actually.

The whole point of the “pause” is to give the FDA time to investigate the prevalence of blood clots in Johnson & Johnson recipients before anyone else is put at risk. (Which will take “days to weeks,” not “weeks to months,” according to Fauci.) Hypothetically, they could find so many that they’re forced to conclude that the odds of being stricken by a dangerous clot after being vaccinated exceed the odds of being stricken by a bad case of COVID if you avoid vaccination. So what is Fauci supposed to say here? He can’t predict what the investigation will determine. If he could, we wouldn’t need an investigation.

The FDA will look at the issue and then draw a conclusion on safety based on where the evidence leads them. That’s all there is to say. All options are on the table.

But let’s approach this another way. Realistically, how many clots would the FDA need to find to convince them that clotting in J&J recipients is a bigger threat than COVID-19 is, such that the product should be pulled from the market? Many, many, many thousands out of the seven million doses that have already been administered, no? And if we’re talking about a prevalence as high as that, one would think that J&J itself would have detected a clotting problem in some meaningful share of the thousands of subjects it tested in its clinical trial. That’s why they do trials, after all, to suss out the common side effects before the drug is publicly available. For J&J to be taken out of circulation permanently would mean a catastrophic failure by the manufacturer to identify a complication that should have been easy enough to identify.

Tiana Lowe puts the currently known risk profile of one clotting incident per million-plus doses in perspective:

Car crashes kill 124 people per million every year, yet we issue driver’s licenses to nearly everyone over 16. Never mind that we even give people second and third chances after DWIs. Just think of all the lives we could save if we just banned driving altogether!

You’re also much more likely to drown than get a mere blood clot from the Johnson & Johnson vaccine. Ten Americans in 1 million die from drowning each year. The number would be much greater than that if we looked only at people who swim on a given day. Should we ban swimming?

Let’s take a look at what the FDA expressly endorses. Acetaminophen (also known as the brand Tylenol) is one of the most widely used drugs in the country, available over the counter, yet, it also sends 50,000 Americans to the emergency room each year for acute liver failure — that is, roughly 154 in 1 million. And again, the number would be much greater if we took as our denominator only those who take acetaminophen. Yet, anyone of any age can buy this drug.

So why can’t Fauci say that? E.g., “I’m fully confident that we’ll resume J&J doses soon. If this blood-clot problem were other than a freak occurrence, we’d have discovered that already. What we want to do is figure out just how uncommon those occurrences are before returning it to the market so that recipients and their doctors can make a fully informed choice on whether to get the shot.” Why lead people to believe the problem might conceivably be so widespread that the vaccine just isn’t fit for human consumption?

Especially since, if they did have to yank J&J, the public’s faith in all available vaccines — Pfizer and Moderna included — would collapse so totally that we’d never get to herd immunity. People wouldn’t trust that the FDA had properly vetted any of the shots before they started going into people’s arms.

Which is a long way of saying of course J&J will be back on the market. But the mere fact that they paused it temporarily will lead some vaccine skeptics to assume the worst when it returns, that it’s still not ready for primetime but is being restored simply because public confidence in the vaccination effort will falter if it isn’t. Or, perhaps, some creative conspiracy-minded people will concoct even more outlandish theories:

It’s weird that he’d reach for a convoluted scenario like “Pfizer pushed Johnson & Johnson” out of the market when he could have gone for the much simpler “Biden’s incompetent FDA should never have approved Johnson & Johnson,” but at least this is a pro-vax conspiracy theory — sort of. If you’re a Trump fan, you’re feeling better about J&J’s product after reading this but worse about Pfizer’s, right?

Exit quotation from Fauci at this same presser: “I don’t think [the FDA] was pulling the trigger too quickly… We are ruled by the science and not any other consideration.” He wasn’t “ruled by the science” when he lied to the public about masks early in the pandemic to protect the existing supply for medical professionals or when he lied about the threshold for herd immunity. He certainly hasn’t been ruled by the science in advising vaccinated people that it’s risky to enjoy themselves in public spaces. And arguably he’s not being ruled by the science in supporting the suspension of a life-saving vaccine during a pandemic due to a one-in-a-million complication.