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Karl W. Smith

The FDA’s Caution on the J&J Vaccine Is a Costly Mistake

The agency has long paid too much attention to the risk side of the risk/reward calculation.

A pause that perplexes.

A pause that perplexes.

Photographer: Stephen Zenner/Bloomberg
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The U.S. Food and Drug Administration’s decision to recommend a pause in distribution of the Johnson & Johnson Covid vaccine has been roundly — and rightly — condemned across the political spectrum. It’s clear that the hypersensitive “abundance of caution” standard the FDA applied is inappropriate for a global pandemic. Less well recognized is that the same standard, applied during normal times, also has enormous costs for lives and health of Americans.

The FDA acted after blood clots were observed in less than one in a million people who have received the J&J vaccine in the U.S. By contrast, Covid has already killed 1,712 out of every million Americans. What’s more, from the information the FDA released initially, it was not clear that any of the blood clots were fatal, though officials later said one woman had died. By its own admission, the agency does not know if there is a causal link between the vaccine and the clotting.