The FDA’s decision to pause the use of Johnson & Johnson's coronavirus vaccine has set off a chain reaction of fear — about the safety of the vaccine, and about whether the FDA is overreacting — that's causing unnecessary drama just as the vaccine effort is finally picking up speed.
The big picture: Throughout the pandemic, the public and the media, and sometimes even regulators, have struggled to keep risks in perspective — to acknowledge them without exaggerating them, and to avoid downplaying them because other people will exaggerate them.
Reality check: The FDA did not say that the Johnson & Johnson vaccine’s risks outweigh its benefits, and it certainly did not cast any doubt on the other two vaccines available in the U.S.
- At the same time, the FDA also is not obligated to keep potentially serious side effects a secret because they will affect fewer people than the coronavirus. Discovering and responding to new safety information is how this system is supposed to work.
Details: The number of reported blood clots is low — just six patients out of the roughly 7 million who have gotten a J&J shot.
- Several other common medications, including birth control, carry a higher risk of blood clots than that. And the coronavirus causes a far higher incidence of blood clots than any of them, in addition to the many other ways in which it is highly dangerous.
- You wouldn’t know that from the immediate reaction to yesterday’s announcement. Axios’ Neal Rothschild notes that of the 20 most-engaged stories on social media about the Johnson & Johnson pause, just two headlines included the context that the blood clots were rare occurrences, according to data from NewsWhip.
That’s part of the reason critics feared the FDA was overreacting, allowing a very small number of adverse events to potentially undermine a very large number of people’s confidence in all-important vaccines. But that criticism is missing some context of its own.
- One woman died from her blood clot, suggesting a potentially serious risk.
- The number of incidents will likely grow, now that doctors and regulators are looking for them more closely. The FDA also said doctors need to be highly attuned to a vaccine-specific risk of blood clots because the standard treatment for blood clots can make this particular type of clot worse.
- All six patients who experienced blood clots in the U.S. were adult women. The effects from Johnson & Johnson’s vaccine are also similar to the side effects from AstraZeneca’s vaccine, and those two vaccines work in similar ways — enough commonality to warrant a closer look.
Between the lines: If some specific group would be better off taking one of the other vaccines, it’s good to figure that out, and to tell people.
What’s next: A federal vaccine advisory committee will meet today to discuss the safety issues.
What we’re watching: J&J has been an important part of the effort to target specific vaccines to specific groups.
- Because it’s only one shot, it’s been especially for useful for hard-to-reach populations that might not get a second shot, including homeless people and inmates. The one-shot dosing has also made it attractive to some younger people.
- Adjusting to two-dose vaccines for at least some of those populations, at least for a while, will pose some challenges.
But the U.S. wasn’t using a ton of J&J doses to begin with, and the federal government has purchased enough of the Pfizer and Moderna vaccines — which have not been linked to any serious side effects — to vaccinate the vast majority of American adults.
- Pfizer said yesterday that it can up its manufacturing capacity to help fill any gaps caused by the J&J pause.
The bottom line: This dichotomy — between exaggerated panic and exaggerated panic about other people’s exaggerated panic — isn’t helping anyone, in the public or in government, make smart decisions.