The FDA is notoriously risk averse, but rational risk assessment must always balance the risk of action against the risk of inaction. Large scale Double Blind testing might be justified for an improved drug for a disease already effectively treated, but it is insanity incarnate in the face of a deadly pandemic.
In vaccine testing, Phase 1 and Phase 2 testing establish the general safety and dosage required to elicit a desirable antibody response. Those have been established for four vaccines, three of which are already under mass production paid for by Operation Warp speed. Phase 3 testing is underway, and administers the vaccines to a larger test group of about 30,000 for each vaccine, divided between active and placebo groups. Phase 3 testing may reveal some less common adverse reactions, but its primary purpose is to measure efficacy in the real world. The time required is open ended as the results cannot be used until enough infections occur in the placebo group to calculate a significant benefit. Because we are getting better at masking and hygiene, that could easily take 4 to 5 months.
But twenty thousand or more Americans are dying every month while we wait for a vaccine.
There is no conceivable risk that could have slipped past Phase 1 & 2 testing that could kill that many, and experience has shown us that even if the vaccines prove to not fully protect us, they will at the least reduce the severity of disease, and we have already paid for the vaccines anyway.
By November we will have 50 million doses on hand, and another 100 million in December, and again in January, enough to provide the first of two required doses to everyone over 70 immediately and to provide their second required dose in December plus the first dose for everyone over 60 with increased risk. By January, the death toll from COVID-19 could be near zero, but that vaccine does us no good sitting in freezers waiting for certainty while thousands die.
No one should be forced to take a vaccine they don’t trust, but rational risk assessment requires that the vaccines be released immediately to older Americans who wish to accept the small risk of the vaccine over the certain danger of the disease.
For healthy younger adults, and certainly for children, waiting for Phase 3 to complete might make sense, as they are unlikely to die if the contract the disease, but for those at significant risk of death from the disease, time is not on our side.
We deserve the right to try.