FDA allowed the safety to be authorized with just two months of median follow-up

Dr. Peter Marks, FDA: "We couldn't speed up time. So in order to get the (COVID) vaccines to people in need when thousands of people were dying, we actually allowed the safety to be authorized with just two months of median follow-up rather than the normal six to 12, but we were confident that that would capture adverse events. So we had good safety data. And then when we went to finally do the biologics license application, we go through very large data sets. For instance, the Pfizer vaccine had 43,000 people involved in clinical trials, about 21, 22,000 of whom had received the vaccine initially, and then thousands more received it after six months. So we went through a tremendous amount of data, looked at the adverse events, and looked at the effectiveness data. So that plus looking carefully at the manufacturing."