Cutting corners on a coronavirus vaccine could cost lives

In the desperation to save lives in the coronavirus pandemic, we have already begun to relax scientific standards in the hope of finding a treatment without waiting to prove that it works.

Bioethicists have proposed risky human-challenge trials — which expose volunteers to the virus — to speed coronavirus vaccine development, and the Trump administration has already let one vaccine maker skip the usual requirement for animal safety trials before injecting an unproven vaccine into the arms of human volunteers.

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The World Health Organization has funded a trial of new drug therapies that shockingly has no placebo-control arm.

And, of course, the experimental and potentially dangerous use of hydroxychloroquine in Covid-19 patients already boasts the presidential seal of approval and has become commonplace in American hospitals.

The next scientific corner to cut is clear.

Influential authors from the Coalition for Epidemic Preparedness Innovations recently wrote in The New England Journal of Medicine that “in a high-mortality situation, populations may not accept randomized, controlled trials with placebo groups.” While placebo-controlled multivaccine trials may be one solution, they wrote, another would be to skip the placebo.

This wouldn’t be the first time doctors took a chance on an unproven vaccine on a mammoth scale.

Read more in my new article at The New York Times.


Posted on April 17, 2020 .