Evaluationofsafetyandefficacy of newvaccines is likely to be especially challengingsince the vaccines might not be available untilafterthe pandemichad started.
The 1960s were when the Food and Drug Administration, in the wake of the thalidomide scandal, started requiring proof of efficacy and long-term safety, and when medicine started relying on clinical trials that compared new treatments to old ones or to inert sugar pills.
Almost immediately, the FDA started receiving reports from patients that claimed the 300mg dose was being associated with side effects and reduced efficacy.