Pausing the J&J Vaccine Was Easy. Unpausing Will Be Hard

Despite the hastily called press conference on Tuesday, the late-night meetings, and the growing worry over a potentially fatal side effect, the decision to pause the use of one of the three Covid-19 vaccines available in the United States was a relatively easy one.

Figuring out how to unpause, though—that’s going to be a lot trickier.

The public health community had some hope that the Centers for Disease Control and Prevention might find a fast path through the data fog. But that vanished late Wednesday, when an emergency meeting of the CDC’s Advisory Committee on Immunization Practices ended without a recommendation. Amid a global pandemic and a race for mass vaccinations, the pause continues pausing.
The vaccine in question is the one made by Johnson & Johnson and Janssen, effective in just a single dose and tolerant of higher storage temperatures than the finicky , two-dose vaccines from Pfizer and Moderna. But one side effect is dangerous blood clotting in the brain, weirdly accompanied by low levels of platelets, the blood component that’s usually responsible for clotting. Technically, the condition’s a cerebral venous sinus thrombosis (that’s the clot in the veins carrying blood away from the brain—basically a stroke) with thrombocytopenia (that’s the low platelet count). Similar issues have shown up in a couple hundred people who got an AstraZeneca vaccine approved in Europe but not the US; researchers studying the problem call it vaccine-induced immune thrombotic thrombocytopenia. After more than 7 million doses of the J&J vaccine administered in the US, just six cases of VITT have shown up, all in women under 50 years old.On the one hand: That’s one-in-a-million odds! But on the other hand: That’s very disconcerting. So on Tuesday morning, officials from the Food and Drug Administration and the CDC recommended a total and complete shutdown on J&J shots until they could figure out what the hell is going on. “Out of an abundance of caution, we’re recommending a pause in the use of the Johnson & Johnson Covid vaccine,” said Janet Woodcock, acting director of the FDA, at the Tuesday briefing. “These events appear to be extremely rare. However, Covid-19 vaccine safety is a top priority for the federal government, and we take all reports of adverse events following vaccination very seriously.”

J&J was on board, too. “We have been working closely with medical health experts and health authorities, and we strongly support the open communication of this information to health care professionals and the public,” read a company statement posted online.

Biden administration health officials promised transparency and honesty in the fight against Covid, and this is what that looks like. But it’s also a real problem in the making. The Johnson & Johnson vaccine was supposed to be the cheap-and-easy one, useful for the most at-risk populations and the ones hardest to reach in the US. It’s also an alternative to more expensive, two-dose mRNA vaccines for the rest of the world , where vaccination rates lag far behind those in the US. Losing it would be a blow to the fight against the pandemic.
Worse, if people are already hesitant to get vaccinated, the FDA and CDC saying one vaccine might give people strokes probably won’t help get more sleeves rolled up—even if the regulators come around later and say that it’s fine, or worth the risk, or only dangerous in certain subpopulations. “Public confidence in this vaccine will take a hit no matter what. I think it was a necessary step to take, given the information we knew and the fact that the treatment required is atypical,” says Jason Schwartz, a health policy professor at the Yale School of Public Health. “There’s going to be a lot of work to do to restore enthusiasm for this vaccine.”