The FDA’s obstacle course is only partly defensible. To be sure, it makes sense to take time to show that a new drug is safe. But that process can actually be done very quickly. You can prove that a drug is safe just by administering it to a thousand people. If no one gets sick, it’s safe. Proving that a drug is effective, on the other hand, takes more time because you need to wait long enough for a test group of people to be expected to have a significant number of cases. Over the past 300 days, a total of 3 percent of the U.S. population has contracted coronavirus. So, it takes 100 days to create a 1 percent probability that members of a test group will catch the virus. Under such conditions it is impossible to prove statistically that a vaccine is effective until after the disease has spread to epidemic proportions.
This situation was made even worse when Moncef Slaoui, head of the Trump administration’s “Operation Warp Speed,” contacted Moderna on August 25 and told them they had to pause the final stage of their testing program until they recruited more minority subjects. This delightful piece of political correctness cost Moderna a month, during which time approximately 40,000 Americans died from coronavirus.