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The Wall St Journal reports “that just 150 or so of the 30,000 or more subjects enrolled in the Phase 3 trials of the leading COVID-19 vaccines need to be infected, and show symptoms, to provide the data to assess” the efficacy (protective ability) for most advanced vaccine candidates. “It just takes a while to get enough events (infections), so you need to have a lot of people in the trial," said Angela Rasmussen, a virologist at Columbia University. “Moderna and Pfizer executives have said they could see initial data in late October or November.”
Once the number of COVID-19 infections required by a vaccine testing protocol has been reached, the study will be “unblinded” to show if it was vaccinated, un-vaccinated, or a combination of the two who became infected.
If most or all of the infected volunteers had received the placebo (i.e. were not vaccinated), this would be strong evidence that infection had been prevented by the vaccine and would allow an early estimate of the vaccine “efficacy”. This information, along with safety / side effect data, may inform an EUA (Emergency Use Authorization) for the vaccine.
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