According to Helen Branswell writing at STAT:
There are serious signs the Food and Drug Administration is getting cold feet over the notion of issuing emergency use authorizations to allow 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 said. “And not only the first vaccine, but maybe even follow-on vaccines.”
This is nonsense. There are many ways to conduct clinical trials while releasing a vaccine—indeed, we can make the clinical trials better by randomizing a phased release. Suppose we decide health care and transit workers should be vaccinated first. No problem–offer the workers the vaccine, put the SSNs of those who wants the vaccine into a hat like draft numbers, vaccine a randomly chosen sub-sample, monitor everyone.This is the well known lottery technique for measuring causal effects often used in the school choice literature. If we use this technique we can greatly increase sample sizes and as we study each wave we will gather more confidence in the data. We won’t have enough vaccine in November to vaccinate everyone or probably even all health care and transit workers so a lottery is an ethically fair as well as statistically useful way to distributed the vaccine. We can also randomize across cities and regions.
Tyrone, never one to mince words, also has good suggestions:
First, they could simply pay people to partake in those trials. Isn’t that in essence what the NBA did with its Covid testing in the bubble? If the value of those clinical trials truly is so high, it should be possible to internalize enough of those benefits to encourage participation. If institutional barriers stand in the way there, let’s obsess over fixing those.
Why should we force so many Americans to be sacrificial lambs, just to subsidize the trial costs? Let those costs be taken out of grant overhead! (And admin. salaries, if need be.)
…Second, there is another way to keep the trial up and running. Approve use of the treatment, but allow the suppliers to charge very high prices! Better yet, use the law to make them charge high prices and if need be forbid insurance coverage.
Or we could use human challenge trials. The ethical objections to such are now looking more and more like nonsense as thousands of people die weekly.
In short, the idea that releasing a vaccine in phases is a threat to clinical trials is a dangerous and false dichotomy and another example of how our leaders lack vision, imagination, and courage.