The FDA needs to approve the COVID-19 vaccines. Right now.

I’ve spent untold hours fighting bureaucracy during the course of my life. Sometimes the issues are big, sometimes small, but I often get incredibly frustrated when I see organizations–and the people who work for them–enforcing rules without thinking, often to the detriment of everyone involved.

Usually, though, bureaucratic rules are little more than annoying time-wasters. They don’t usually cause actual harm to people. Right now, though, the FDA’s failure to fully approve the Covid-19 vaccines, and its rigid adherence to its own rules, is not just wasting time. It’s killing people, albeit indirectly.

The FDA needs to approve the Covid-19 vaccines, and they need to do it now. They claim to be working hard on doing just that. The vaccines have already been administered to hundreds of millions of people, and the ones used in the U.S. and Europe have proven to be remarkably safe and amazingly effective. So what is the FDA waiting for? Well, according to them, they have to wade through the paperwork.

As nearly everyone knows, here in the U.S. we have three approved vaccines against SARS-CoV-2, from Pfizer-BioNTech, Moderna, and Johnson & Johnson. The first two are messenger RNA (mRNA) vaccines, an innovative design that is strikingly effective, reducing the chance of infection by over 90%.

The U.S. now has an ample supply of vaccines, but we are struggling to get everyone vaccinated, in large part because so many people are either hesitant to get the vaccine or downright opposed. Let’s leave aside the blatant anti-vaxxers for today, many of whom are so deeply misinformed that changing their minds is probably impossible.

A much bigger problem, and one that we can fix, is the far larger number of people who are waiting for the vaccines to get full FDA approval. Not only are many individuals waiting, but many large institutions, including the U.S. Defense Department, have announced that they will mandate vaccines for their personnel once the FDA formally approves them.

Right now, the 3 vaccines in the U.S. are only conditionally approved, under the FDA’s Emergency Use Authorization (EUA). The fact sheet that the FDA provides with these vaccines includes a number of caveats, and states that “there is no FDA approved vaccine to prevent Covid-19.” That statement is not, to put it mildly, very convincing.

Full approval requires the FDA to review “hundreds of thousands of pages of documents,” a process that usually takes 10 months, or maybe six months for a “priority” application. Pfizer only submitted its paperwork on May 7, and Moderna on June 1, so even the FDA’s priority process would leave us without an approved vaccine until the end of 2021. That’s just too long.

I’ve heard the FDA’s excuses. The FDA’s Director of Biologics, Peter Marks, explained in a letter to the NY Times that

“any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy.”

Sorry, Dr. Marks, but these excuses are nonsense. The Covid-19 vaccines have been rolled out with unprecedented speed, it’s true, but we’re now seeing the results of a real-time, real-world experiment on hundreds of millions of people, and–luckily–the results are great! Have you and your colleagues at the FDA not noticed this?

Furthermore, everyone knows that the vaccines will be fully approved in the next few months, and multiple government officials, including the President, have said so quite openly. So why not approve them today? Because you have to follow a set of bureaucratic rules that were not designed for a pandemic?

The virus doesn’t care about the rules. Infections in the U.S. are skyrocketing again, because of the Delta variant, and the only way to end this pandemic is to get nearly everyone vaccinated. Until we have full approval of the vaccines, we’re simply not going to get there. By relying exclusively on the paperwork provided by the vaccine manufacturers, and ignoring the enormous amount of real-world data that everyone can see, the FDA is prioritizing process over results.

The FDA says that it’s now in a “sprint” to approve the vaccines, but with every day that passes, more people get sick, and the virus has more time to mutate and become more deadly.

Listen, FDA: rules are created for a reason. In case you haven’t noticed, the pandemic is a worldwide emergency that cries out for you to bend or break the rules if doing so will save lives. We all want a safe and effective vaccine, but there’s an overwhelming amount of evidence that we already have at least 3 of them (and probably 6 or 7). You can approve the Pfizer-BioNTech and Moderna vaccines today, and if new data emerges, or if you discover something startling and unexpected in those millions of pages of paperwork, you can withdraw approval. There’s nothing preventing this except bureaucracy.

So don’t tell us that you (FDA) have to “complet[e] the high-quality review” or you’ll somehow be shirking your responsibility. That response is equivalent to saying “we can’t look at the overwhelming evidence from the real world, we can only look at the paperwork that the vaccine companies provided to us.” In other words, “nanner nanner we can’t hear you” rather than considering the fact that hundreds of millions of people have taken the vaccine and that it’s working.

And about that comment from the FDA about maintaining public trust? As Dr. Eric Topol pointed out in a recent op-ed, somehow the FDA managed to approve, in the midst of the pandemic, an incredibly expensive new Alzheimer’s drug (aducanumab) for which the evidence of effectiveness is very thin, and the risks of harm are very real. The FDA’s own advisors resigned in protest, and now the FDA’s inspector general is going to take another look at how this happened. And yet the FDA is worried about “public trust in the agency”? Give me a break. Meanwhile, the FDA can’t seem to find the time to approve the mRNA vaccines “despite massive evidence of their benefits.”

The FDA needs to stop hiding behind the mountain of paperwork. Millions of people will remain unvaccinated while the FDA reviews documents that merely tell us what we already know: the vaccines work, and they are safe. Give them full approval, today, and continue to monitor their safety carefully, and many lives will be saved.

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