On Monday August 23rd, the Food and Drug Administration formally approved the use of the Pfizer-BioNTech Covid-19 vaccine. The vaccine had finally crossed the regulatory finish line.
Drug approval in the United States is under the auspices of the Center for Drug Evaluation and Research, an important branch of the FDA. The center’s job is to evaluate drugs before they are sold, specifically determining their safety and effectiveness, and to assure that the benefits of their administration outweigh the risks. The center is also responsible for supplying information regarding the drug to doctors nationwide, so it can be administered to patients responsibly and effectively.
It is a vitally important job, and the FDA cannot afford to be wrong as people's lives are at stake.
But wait a minute.
If the FDA just approved the vaccine for use at the end of August, how was it possible that it has been injected into so many arms prior to that? Just what kind of chicanery is the Federal Government up to?
The answer is none, and the reason is that in November 2020 the vaccine received emergency use authorization from the Feds, which allowed it to be used prior to running the full gauntlet of the drug approval process. When there is an emergency that can prejudice the health of the American public, the emergency use act permits the FDA to authorize an unapproved medical product, in this case the vaccine, for public distribution.
Good idea? Of course, it is.
For one, the lack of formal approval does not imply Federal irresponsibility. Emergency authorization comes with its own scrutiny, albeit less robust than that of a full approval. Second, full approval takes times. In the face of an impending public health crisis, time is not always a luxury that the FDA can afford. Sometimes putting a drug into circulation is warranted, even if the evaluation of it is not fullly complete.
Emergency authorization use, regardless of its utility and importance, is a regulatory band-aid, a temporary fix. It is used to provide the best care to Americans when they are being confronted with a potentially catastrophic public health threat, but the band aid, at some point has to come off. Consequently, it is imperative that the FDA approve drugs and vaccines, providing that they are safe and effective, even after emergency authorization use is applied.
In the case of the Pfizer-BioNTech vaccine, FDA approval caused an almost immediate uptick in vaccination rates across the United States. Clearly, the American public still has trust, and place faith and value, in the FDA. FDA approval of the Pfizer-BioNTech vaccine is very good news, not only on its face value, but also for the psychological confidence that approval provides to the American public.
The Pfizer-BioNTech vaccine has crossed the regulatory finish line.
Wave the checkered flag!