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The Price of Success—How to Evaluate COVID-19 Vaccines When They’re Available Outside of Clinical Trials

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To identify the key insights or developments described in this article
1 Credit CME

In science, as in other fields of endeavor, success can have unexpected consequences.

Take the debut of 2 highly efficacious coronavirus disease 2019 (COVID-19) vaccines more quickly than anticipated.

The situation has spurred debate about the ethics, let alone the feasibility, of continuing or launching blinded, placebo-controlled trials—generally considered the gold standard of medical research—of investigational COVID-19 vaccines.

“This is unprecedented and took almost everybody by surprise,” bioethicist David Wendler, PhD, of the National Institutes of Health Clinical Center, said in an interview.

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In science, as in other fields of endeavor, success can have unexpected consequences.

Take the debut of 2 highly efficacious coronavirus disease 2019 (COVID-19) vaccines more quickly than anticipated.

The situation has spurred debate about the ethics, let alone the feasibility, of continuing or launching blinded, placebo-controlled trials—generally considered the gold standard of medical research—of investigational COVID-19 vaccines.

“This is unprecedented and took almost everybody by surprise,” bioethicist David Wendler, PhD, of the National Institutes of Health Clinical Center, said in an interview.

In regularly consulting with Operation Warp Speed—the federal government’s COVID-19 vaccine accelerator—Wendler said, he couldn’t recall anyone suggesting that 1 vaccine, let alone 2, would demonstrate 95% efficacy against symptomatic disease by December 2020.

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