On Tuesday morning, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention recommended “out of an abundance of caution” that states pause the use of Johnson & Johnson’s single-dose COVID-19 vaccine. The move came after reports that six of the millions of Americans to receive it — all of them women between the ages of 18 and 48 — developed an “extremely rare” form of blood clotting within weeks of getting their shot.
As with everything these days, reaction to the sudden announcement immediately split experts and commentators into two warring camps.
One side worried primarily about vaccine hesitancy, arguing that the risk of clotting was too minuscule — and the proven benefits of the J&J vaccine too massive — to justify delaying potentially lifesaving doses and undermining public confidence in the vaccine.
The other side focused primarily on health, arguing that federal agencies acted responsibly by moving to prevent further clots until medical professionals are prepared “to recognize and treat patients appropriately,” as Principal Deputy Director of the CDC Anne Schuchat put it Tuesday.
So who’s right?
The hesitancy argument is relatively straightforward, and it has been advanced primarily by pundits who obsess over politics (and political messaging) for a living — people like data journalist Nate Silver of FiveThirtyEight.
“6 cases out of 7 million people,” Silver tweeted Tuesday. “What a disaster. This is going to get people killed. And it’s going to create more vaccine hesitancy. These people don’t understand cost-benefit analysis. They keep making mistakes by orders of magnitude.”
Silver went on to explain why, based on the numbers, he doesn’t think it should have even been “a particularly close decision.”
“Say there’s a 1 in 100 chance someone acquires COVID because of a delayed vaccine (maybe conservative in the US where spread is still quite high) and a 1 in 150 chance they die from it,” he wrote. “That’s a 1 in 15,000 chance vs. 1 blood clot death in 7,000,000 doses so far.” (One J&J vaccine recipient died from clotting.)
“Even if blood clot deaths were 10-fold higher than observed so far, which is certainly possible, it wouldn’t be a close decision,” Silver continued. “And that’s before considering the knock-off effects on contributing to vaccine hesitancy.”
Other political commentators expressed similar concerns about increased hesitancy at a time when many remain wary of the brand-new COVID-19 vaccines (despite copious evidence of their safety and effectiveness), citing the media’s inability to properly explain the situation and the public’s inability to understand relative risk.
“I am extremely skeptical of the ability of public messaging to disaggregate ‘the J&J vaccine is under review as a precaution’ from ‘the J&J vaccine is not safe and the others may not be either’ in the minds of normal people,” wrote Matthew Gertz, a senior fellow at Media Matters. “This seems like a pretty massive risk to take over a one-in-a-million risk against a virus with a U.S. body count of more than 550,000.”
“Is it possible that the FDA is going to increase vaccine hesitancy here, rather than lower it? Definitely,” added Ezra Klein of the New York Times. “Let’s say, in three days, they clear J&J totally. Will that get the news coverage the pause did? Will it fully end the fears the public now has? I doubt it.”
The latest Yahoo News/YouGov poll showed that while 37 percent of unvaccinated Americans plan to get a shot, 38 percent don’t and another 25 percent say they’re unsure.
Scientists, however, have tended to respond differently: by emphasizing that the pause is soft, temporary, normal and even necessary from a medical perspective — and that alarmist headlines and ill-informed vaccine resistance will persist regardless of what regulators do.
The truth, scientists say, is that the proper treatment for the specific type of clotting observed in those six female Johnson & Johnson recipients — cerebral venous sinus thrombosis (CVST) in combination with low levels of blood platelets (thrombocytopenia) — is different from the treatment that a doctor might typically administer for blood clots. In fact, the typical treatment, an anticoagulant drug called heparin, may be fatal in this scenario.
Given that millions of doses of the Johnson & Johnson vaccine have already been administered in recent days and that authorities don’t know how many additional cases of CVST have yet to surface, federal agencies decided that a pause — likely brief, and likely followed by new guidance — was the most transparent way to alert health workers and patients about symptoms and treatment while minimizing future problems.
“Let’s start with what the FDA didn’t do: They didn’t revoke the EUA [emergency use authorization], they didn’t order this off the market. This was a requested pause, which is an awkward regulatory step, but it reflects a level of caution not to appear too forcefully here,” said former FDA Commissioner Scott Gottlieb. “For most consumers, I wouldn’t be concerned about this. Really this is an alert to doctors … to be monitoring more closely.”
“A pause is not permanent,” wrote Natalie Dean, an assistant professor of biostatistics at the University of Florida specializing in emerging infectious diseases. “The risk-benefit profile depends upon age, likely sex, and population incidence. As we’ve seen in Europe” — where similar issues arose with another adenovirus-based vaccine, by AstraZeneca — “one path forward may be vaccination policies that vary by age, sex. Understanding the causal mechanism may help us develop targeted policies and potential treatments.”
On a call with reporters Tuesday, FDA and CDC officials were clear that they “expect it to be a matter of days for this pause” and that the interruption is unlikely to have “a large adverse effect on [the U.S.] making [its vaccination] goals in a timely manner, if at all.” An emergency meeting of the CDC’s outside advisory committee is scheduled for Wednesday.
So while critics such as Silver say federal agencies should have handled the situation differently to avoid inflaming vaccine skepticism — “Say you’re continually monitoring complications and this rare event doesn’t warrant a pause at the current time but of course you’ll investigate further,” Silver suggested, or “pause only for 16-49 year old women,” or “quietly investigate and *then* announce the results” — it’s entirely possible that less transparent approaches such as these would have made things worse, not better.
“Think of it this way: It’s pretty hard to claim there’s a vast conspiracy to suppress secret deaths and side effects when the whole damn system literally stops because it found 6 cases of a thing out of 7 million doses,” wrote FiveThirtyEight science reporter Maggie Koerth. “Weird how a super rare side effect was found and action taken all without the help of ‘activists’ making videos on YouTube. IT IS ALMOST AS IF THE FDA CARES ABOUT THE RISKS OF VACCINES AND IS WATCHING FOR THEM.”
It’s also entirely possible the Johnson & Johnson pause could be over before most people even know it — with heightened medical awareness and new, targeted precautions in place, but without the kind of spiraling loss of confidence that many commentators fear.
“There is no perfect way for FDA/CDC to handle this without being seen as withholding information or putting lives at unnecessary risk,” explained Howard Forman, a professor of public health at Yale.
“If they didn’t ‘pause,’ we would have unnecessarily vaccinated certain groups without giving clinicians and their patients enough info to make a decision. By Friday, this could be easily resolved.”