Failing the Challenge

CNN says “In one word, this is why there likely won’t be a vaccine available before Election Day: biology.” Wrong. The one word is complacency. What CNN refers to as biology is the time it takes to run clinical trials.

Here’s how the trials work: You take 30,000 people, give half of them a vaccine and half of them a placebo, which is a shot of saline that does nothing. Then those 30,000 people go about their lives, and you wait to see how many in each group become infected and sick with Covid-19, the “endpoint” in medical parlance.

That waiting takes time, especially since the coronavirus vaccines currently being studied in the US are two-dose vaccines with each dose several weeks apart.

But it gets worse because trial volunteers are not random:

“Who’s in the trials – the kind of people who tend to stay at home or the kind of people who attended the Sturgis rally?” said John Moore, an immunologist at Weill Cornell Medicine, referring to a motorcycle rally in South Dakota that led to at least dozens of cases of Covid-19.

Historical precedent, as well as the demographics of the participants in the current coronavirus vaccine trials, suggest more the stay-at-home type.

That does not bode well for bringing the trials to a speedy conclusion.

Typically, those who volunteer for clinical trials tend to be “White, college-educated women,” said Frenck, who has been the principal investigator on dozens of vaccine clinical trials, and has served on the Data and Safety Monitoring Board for many others.

All three of those factors are potentially bad news for the coronavirus clinical trials, because data indicates White college-educated women are at lower risk for being exposed to the novel coronavirus.

None of this, however, is actually about biology. It’s about complacency. We could have run human challenge trials and paid for diverse volunteers but we decided that was too risky or too new or too radical or too something and so thousands of people die every week as we wait.

Addendum: Previous posts on challenge trials.


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