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How to Vaccinate and Continue Clinical Trials

According to Helen Branswell writing at STAT:

There are severe indicators the Food and Drug Administration is getting chilly ft over the notion of issuing emergency use authorizations to permit for the widespread early deployment of Covid-19 vaccines.

…“We are concerned about the risk that use of a vaccine under an EUA would interfere with long-term assessment of safety and efficacy in ongoing trials and potentially even jeopardize product approval,” Gruber mentioned. “And not only the first vaccine, but maybe even follow-on vaccines.”

This is nonsense. There are some ways to conduct medical trials whereas releasing a vaccine—certainly, we will make the medical trials higher by randomizing a phased launch. Suppose we resolve well being care and transit staff ought to be vaccinated first. No downside–supply the employees the vaccine, put the SSNs of those that needs the vaccine right into a hat like draft numbers, vaccine a randomly chosen sub-sample, monitor everybody.This is the well-known lottery approach for measuring causal results typically used within the school choice literature. If we use this method we will drastically improve pattern sizes and as we research every wave we are going to collect extra confidence within the information. We received’t have sufficient vaccine in November to vaccinate everybody or most likely even all well being care and transit staff so a lottery is an ethically truthful in addition to statistically helpful option to distributed the vaccine. We can even randomize throughout cities and areas.

Tyrone, by no means one to mince phrases, additionally has good suggestions:

First, they may merely pay individuals to partake in these trials.  Isn’t that in essence what the NBA did with its Covid testing within the bubble?  If the worth of these medical trials really is so excessive, it ought to be potential to internalize sufficient of these advantages to encourage participation.  If institutional obstacles stand in the way in which there, let’s obsess over fixing these.

Why ought to we power so many Americans to be sacrificial lambs, simply to subsidize the trial prices?  Let these prices be taken out of grant overhead!  (And admin. salaries, if want be.)

…Second, there’s one other option to maintain the trial up and working.  Approve use of the therapy, however permit the suppliers to cost very excessive costs!  Better but, use the regulation to make them cost excessive costs and if want be forbid insurance coverage protection.

Or we might use human challenge trials. The moral objections to such at the moment are trying increasingly more like nonsense as hundreds of individuals die weekly.

In quick, the concept that releasing a vaccine in phases is a menace to medical trials is a harmful and false dichotomy and one other instance of how our leaders lack imaginative and prescient, creativeness, and braveness.

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