What Does the FDA Monitor During Vaccine Clinical Trials?

What Does the FDA Monitor During Vaccine Clinical Trials?

I am Stanley Plotkin, Professor Emeritus of Pediatrics at the University of Pennsylvania.

The FDA insists — as it properly should — on scientifically valid trials of vaccines. By that I mean that the trials be conducted in a manner which is blind to the observers; that they do not know who received the vaccine and who received the control; and the trials are conducted in various stages, one begins with so-called Phase I, the earliest tests, and then goes to Phase II, which involves more people and longer observation periods, and then the critical so-called Phase III trial, which is a test of safety and efficacy in large populations. The FDA insists that those trials be conducted in a double-blinded manner and also that the observations be thorough and complete, and at the end of the day, they will look at the safety observations and also whether the disease for which the vaccine was developed occurs in the control population but not in the vaccinated population.