4. Proven safer than the disease by a factor of at least 100x
Does not apply. chance of having many of the diseases are well below 1%, thus vaccine has to be 100x safer than the disease. With COVID, we are talking at least 10%, if not 50% depending on age and lifestyle. Thus, you just need to prove that vaccine is 10x safer than the disease. This essentially means that we should have started giving vaccines to nursing home residents before Phase 3.