How does one demonstrate efficacy in such a trail? Give 100 people the vaccine, then expose all 100 to the virus, and see who get's sick? Then do the same with 100 people who did not receive the vaccine, to establish a control with which to compare the effect. While 100 people wouldn't be mathematically valid to generalize to a population of 7 billion, and there are ethical issues with intentionally infecting people.
I've read some clinical trials of other drugs that follow the control model, with volunteers - people who are already sick and usually untreatable. That sort of control can show a difference between no meds and meds in treating a condition, but how does one validate prevention of a condition? From the literature it seems typically a lot of ad-hoc methods masquerading as science are used. I didn't see data on the pre-release clinical trial because what I found on the FDA site made it look like there was none prior to the EUA.
How does one demonstrate efficacy in such a trail? Give 100 people the vaccine, then expose all 100 to the virus, and see who get's sick? Then do the same with 100 people who did not receive the vaccine, to establish a control with which to compare the effect. While 100 people wouldn't be mathematically valid to generalize to a population of 7 billion, and there are ethical issues with intentionally infecting people.
I've read some clinical trials of other drugs that follow the control model, with volunteers - people who are already sick and usually untreatable. That sort of control can show a difference between no meds and meds in treating a condition, but how does one validate prevention of a condition? From the literature it seems typically a lot of ad-hoc methods masquerading as science are used. I didn't see data on the pre-release clinical trial because what I found on the FDA site made it look like there was none prior to the EUA.