FDA

The Pandemic Could Have Been Over Much Sooner—If Not for the FDA

At critical junctures, the FDA slowed vaccine development and rollout. Its decisions almost certainly cost lives.

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The pandemic isn't over—but it's over, at least in the United States. That's welcome. But it could have been over so much sooner if not for the Food and Drug Administration (FDA). 

Let's start with where we're at. After spiking over the winter, new coronavirus cases and deaths have both dropped dramatically—not to zero, but enough that, in combination with vaccines, local leaders are lifting many pandemic restrictions. 

Even deep-blue cities and states that put in place the strictest pandemic restrictions are moving rapidly toward reopening. In Washington, D.C., where I live, Mayor Muriel Bowser announced this week that the District would become the latest locality to lift a longstanding mask rule, following updated Centers for Disease Control and Prevention (CDC) guidelines last week. New York City will allow restaurants to return to something close to full capacity this weekend. And many lingering restrictions are scheduled to end in the coming weeks and months. 

Yes, the governor of New Jersey is still requiring masks, against CDC guidance. And yes, there are still large groups of people—a disproportionate number of them Republicans—who are still declining to be vaccinated. The virus will linger at some low level, and so will some restrictions. But as the summer goes on, life in most places in America will return to something resembling normal.

Like I said: It's not over—but it's over. 

In some ways, this was a fairly rapid recovery, at least compared to what many were predicting last year. Last summer, Anthony Fauci, the country's lead infectious disease expert, predicted a 12–18 month timeline for the development of effective vaccines. But the first vaccine application was in by November 2020 and approved the following month. The first non-trial dose of the vaccine was administered on December 14. And while the rollout was not without hiccups, by April 2021, every adult in America was eligible to get one. 

Yet as relatively speedy as all this was, it might have happened even faster, and perhaps even mitigated the winter spike in coronavirus cases that killed so many, had federal drug regulators not stood in the way. 

We will be debating the effectiveness and legality of coronavirus policies for a decade or more (one possibility is that none of those policies made much difference in any direction). But the clearest lesson from this last year or so is that the COVID-19 vaccines work, and the faster you can roll them out to the public, the sooner your pandemic will be over.

So I think it's worth imagining an alternate timeline in which the FDA had not slowed the drug rollout at critical junctures, costing lives and allowing deep social disruptions to persist for longer than necessary.

The decline in death in the United States tracks almost perfectly with vaccination. You can see similar correlations in other countries that have widespread vaccination, such as the U.K. and Israel, which has vaccinated even more of its population than the United States. Everywhere there is broad vaccination, deaths and hospitalizations have dropped dramatically. The way to end a pandemic is with an effective vaccine that is widely available. 

This means the priority for policymakers should be to get jabs in arms as soon as the laws of physics will allow. And at several key points last year, the FDA slowed the process down. 

The most glaring example of the FDA slowing down the process was at the very end. After conducting multiple, increasingly large clinical trials throughout the year, as the FDA requires, Pfizer-BioNTech submitted an application for emergency use authorization on November 20. The relevant FDA panel did not meet to approve the request until December 10, which meant the first vaccine was not administered until December 14. 

The FDA could have met immediately, on an emergency basis, reviewing paperwork and data collection on a rolling basis so that by the time the application came in, they were ready to give it the go-ahead. This is not some hypothetical alternative that doesn't work in the real world; it is what drug regulators in the U.K. did last year. (The U.K. is not known for being especially lax with drug regulation.) If the FDA had been willing and ready to approve the vaccine on the day the application was submitted, the vaccine rollout could have started weeks earlier. 

Given the clear real-world evidence of the vaccine's effectiveness not only at preventing death in the vaccinated but at reducing transmission to others (and thus slowing spread at a population level), those weeks could have saved tens of thousands of lives. 

Ostensibly, the reason for the lag time between submission and approval was that the FDA needed time to review the documentation—confirming the safety of the vaccine, and ensuring public trust in the process. At best, that's a political judgment based on little evidence; at worst, it's a cover for maintaining the FDA's regulatory bottleneck on drug development. 

And it's not clear that either public trust or public health are served by delaying the rollout of a life-saving, society-altering treatment. It's hard to avoid the conclusion that the FDA let some number of people die in service of upholding a bureaucratic process. That's supposed to increase public trust in the system? 

An even bigger mistake came earlier in the process. The current drug testing regime for vaccines consists of three primary phases, the last of which is an expensive, time-consuming, large-scale controlled experiment, in which thousands of people who get the vaccine are tracked and compared against thousands of people who get a placebo. Pfizer-BioNTech's Phase Three trial started last summer, at the end of July

Those large-scale randomized trials help determine safety, sussing out potential complications or rare side effects in large groups of people. But it's possible to determine efficacy much more quickly, via a process known as human challenge trials, in which volunteers are intentionally, directly exposed to the virus. Human challenge trials provide actionable data much faster and with far fewer subjects than more conventional large-scale trials, making them particularly excellent tools for emergencies, when the priority is to move quickly. 

Some medical ethicists are opposed to these trials on the grounds that to directly expose someone to a potentially deadly virus would be to do harm. But it's possible to mitigate those concerns by drawing from healthy cohorts who have much lower risk levels (young, healthy adults, for example), by providing volunteers with priority care, and by paying volunteers to take on some level of increased personal risk, as we often do with dangerous professions. 

As with rolling review, human challenge trials are not impractical in the real world. In February, the U.K. approved compensated COVID-19 human challenge trials, with some conditions, in hopes of "helping to identify the most effective vaccines and accelerate their development." 

These sorts of trials, however, could have been approved here in the United States by the FDA last year, dramatically speeding up the final phase of testing. As Reason's Ron Bailey has written, if the FDA had allowed human challenge trials last summer, we might have had public access to vaccines as early as September 2020. 

On the one hand, that's just a few months earlier. On the other hand, consider the difference that just three or four months of vaccine rollout might have made—potentially heading off, or at least reducing the impact of, the huge surge in cases and deaths that came during the winter. 

There's a huge difference between America in December 2020, when the first doses of the vaccine rolled out, and America in March 2021, when millions of people (particularly the vulnerable elderly) had received at least one dose. The first is a country in the midst of a public health catastrophe killing thousands per day. The second is a country in which cases and deaths are down dramatically, and set to decline even further. 

Even a limited number of doses of the vaccine starting in September could have protected the elderly, could have helped slow the spread of the virus and partially prevented the winter surge. 

And that might have been a possibility, if not for the FDA, which repeatedly stalled the testing, development, and rollout of the vaccines in the name of safety—a concern that probably led to the deaths of thousands. 

There were other decisions that affected the vaccine timeline and takeup as well: The FDA has so far declined to approve AstraZeneca's vaccine, despite it being approved for use elsewhere (including, again, in the U.K.), and stuck with a strictly timed two-dose regimen for the Pfizer and Moderna vaccines, despite evidence that those vaccines provide considerable immunity around two weeks after the first dose. In March, the agency paused delivery of Johnson & Johnson's vaccine in response to a tiny number of reports of potential adverse side effects, which may have contributed to the slowing vaccination rate since. The FDA, in other words, is still slowing down the use of the most effective tool we have in fighting the pandemic in ways that are incredibly consequential. 

So it's not just that the pandemic might have been over sooner, allowing many to return to normal lives, although that's true and important. It's also that, if things had gone differently, if the FDA had made different decisions and access to vaccines had become available just a little sooner, there might have been many more lives that could return to normal.