“What is the FDA waiting for?”
As the Delta variant coronavirus sweeps through the country, the Food and Drug Administration is supposedly working hard to give final approval to the mRNA vaccines that have helped stem the lethal COVID-19 tide.
The question is…why is it taking the FDA so long to arrive at this final decision, particularly as final approval ma help convince even more people to get vaccinated?
As Cato’s Jeffrey Singer writes,
Responding to calls to speed up the process, the FDA announced in mid‐July that an answer to Pfizer’s request is “likely to come much sooner” than the January 2022 deadline. Some think it might come in two months.
But the Delta fire still rages. How many months before a vaccine‐resistant variant evolves? The FDA is taking too long. It already has data from what amounts to real world clinical trials in the U.S. of roughly 350 million doses given.
The evidence shows there are minimal major side effects or unusual adverse events associated with the mRNA vaccines. In fact, their safety profile is extraordinarily good.
It is rare that the FDA has an opportunity to view the real‐world effects of a vaccine or drug on such a large population group in such a compressed time frame. Ordinarily, it takes several years to get data on these many millions of vaccine recipients.
The FDA should give full approval posthaste. Hopefully, this will remove the stigma of “experimental drug” that is keeping many people from getting themselves vaccinated—an action that could, quite literally, save their lives and prevent a more deadly variant from emerging.
Exactly. Clinging to old, bureaucratic ways only prolongs hesitancy in some populations, and increases the danger for us all.