Data: CDC and Simon Willison; Chart: Danielle Alberti/Axios 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, Axios' Sam Baker reports. 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.
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.
What's next: A federal vaccine advisory committee will meet today to discuss the safety issues. Go deeper. |
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