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Lack of FDA COVID vaccine 'approval' doesn't matter

In the practical sense, there is little difference between a vaccine that was “authorized” rather than “approved.” Its efficacy is the same.

This article was originally published in the Montreal Gazette

Well, we did it. Sort of. We got through a long and brutal winter with only a minimal number of trash cans being set on fire by protesters who thought that breaking store windows would somehow stop a virus from spreading. The vaccines are rolling out. COVID cases are trending downward, albeit slowly. So as long as we don’t lull ourselves into a false sense of security and forget that many countries around the world are still being ravaged by COVID-19, then we should be relatively OK. As long as people get vaccinated.

Relative to the United States, we are doing well. A recent survey found that more than 80 percent of Canadians had got or intended to get a COVID-19 vaccine, which is up from previous surveys. This is an encouraging sign. But as we learned with the resurgence of measles, if enough people refuse vaccination, there could be future outbreaks.

Unfortunately, there is a lot of misinformation circulating out there and some individuals are using people’s fear to turn them against the vaccines. And while trying to combat vaccine misinformation is like a game of whack-a-mole, with new claims popping up just as you debunk others, we can at least address some of the more widespread and enduring arguments used against the vaccine rollout.

A common argument you will likely see in one form or another, is that the vaccines were never actually approved by the U.S. Food and Drug Administration. Setting aside for a moment the fact that what the FDA does shouldn’t actually matter in Canada, where such matters are determined independently by Health Canada, the lack of FDA approval of these vaccines doesn’t actually matter.

Many people interpret the lack of FDA approval to mean that the vaccines have not been properly tested and are therefore suspect, but this is a misrepresentation of the facts. The FDA actually granted these vaccines something called Emergency Use Authorization (EUA). An EUA is “a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies.” In short, it allows the FDA to roll out treatments in short order during an emergency like the COVID-19 pandemic. It is important to remember that EUAs were used not just for vaccines, but also for treatments like convalescent plasma and the ill-conceived flirtation with hydroxychloroquine as a COVID treatment.

EUAs have the advantage of speed. In a pandemic, delays cost lives. When, as with COVID-19, you initially have no good treatments at your disposal, you sometimes do the best you can with the data at hand and try treatments based on preliminary data. With time and more research, you either confirm that treatments work, or discover that they do not. The main advantage of an EUA is that it can be revoked if it looks like something is ultimately ineffective. The FDA revoked its EUA for hydroxychloroquine (plaquenil) after it became clear that it did nothing against COVID-19.

People who advocate against vaccines, and these vaccines in particular, will use doubt to shake your confidence in the vaccines’ safety and effectiveness. They would have you believe that EUAs mean that these vaccines were unleashed unto an unsuspecting public with nary a second thought, rather than as the consequence of months-long clinical trials involving tens of thousands of patients with dozens of follow-up studies since. And if you are unwilling to rely on the data from randomized trials, then you can look around and see for yourself what a mass vaccination campaign can accomplish.

In the practical sense, there is little difference between a vaccine that was “authorized” rather than “approved.” Its efficacy is the same. If a rose by any other name smells just as sweet, then a vaccine by any other designation still works and save lives.


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