Earlier this week, the Food and Drug Administration called for a pause in the use of Johnson & Johnson’s Covid-19 vaccine, to evaluate its association with extremely low risks of serious blood clots. On Wednesday, this pause was effectively extended for another seven to 10 days. Many are worried that the FDA’s decision to temporarily halt distribution in the first place has unnecessarily sidelined a key vaccine in the middle of a pandemic. It slows the pace of vaccination and potentially increases vaccine hesitancy, which makes it harder to reach the herd immunity threshold, even if Johnson & Johnson is subsequently cleared for use.
But what critics are missing is that making the difficult decision to pause Johnson & Johnson vaccination while evaluating safety concerns may, counter-intuitively, help the US defeat Covid-19. This incident should inspire confidence in Americans that the FDA takes all safety concerns, no matter how rare or unlikely, seriously. Increased trust in the system would enable the FDA to be a more effective regulatory body and help get the pandemic under control—even if it comes at the expense of confidence in the Johnson & Johnson vaccine. What’s more, any potential fallout from the pause can be mitigated in several ways that will also have positive ripple effects in fighting the pandemic and improving public health overall.
It’s important to remember the FDA’s broader purpose. The agency is entrusted with regulating medical, cosmetic, and food products, the use or consumption of which, for the most part, cannot be undone. If the FDA has to reverse an authorization or approval, the fallout could be large—both in terms of the FDA’s reputation and the impact on American consumers. In order to feel confident enough to get vaccinated in the first place, most people would need to be quite sure that the authorization or approval decision wouldn’t be reversed in the future. Even the occasional reversal could make people much more skittish about getting vaccinated at all. It therefore makes sense for the FDA to act in an abundance of caution and take measures, even seemingly extreme ones such as delaying a decision, to avoid having to do that. In light of these considerations, the FDA decision to pause Johnson & Johnson while it conducts a review of the data is justifiable.
An effective FDA relies heavily on trust, which is hard to regain if it’s lost. Few Americans have the time or expertise to evaluate the scientific data on vaccine safety and effectiveness themselves. Being transparently and predictably cautious makes it easier for the public to interpret FDA decisions and feel confident in them, which, in turn, boosts take-up of authorized and approved vaccines. Pausing Johnson & Johnson vaccinations while the data is reviewed, despite the potential repercussions from canceled vaccination appointments, sends a clear message that the FDA is taking all safety concerns seriously. An evaluation could have been done quietly or without pausing vaccinations, but transparency even in, or especially in, the face of bad news inspires confidence in the system.
It’s also critical to keep in mind that Johnson & Johnson isn't the only vaccine under the FDA’s watch. Any missteps impacting trust in the agency would therefore be extremely costly, affecting Americans’ perception of all Covid vaccines. An oversight in addressing safety issues for one vaccine could undermine confidence in other approved vaccines, most of which we will rely on long after the pandemic ends. Not to mention, the FDA also is responsible for all drugs, medical devices, cosmetics, and the food supply, so ripple effects from a loss of trust could spread widely and hurt public health in countless ways down the road.
There is therefore more at stake in the Johnson & Johnson decision than most people realize. Failing to pause when it was perceived to be necessary would tarnish the FDA’s reputation and undermine trust in its other decisions. Sacrificing consumer confidence in the Johnson & Johnson vaccine to preserve or even increase confidence in other authorized Covid-19 vaccines would be a worthwhile trade-off.
The fact that we are in the middle of a pandemic raises the stakes of FDA decisions but doesn’t change the fundamental balance of these considerations. The Emergency Use Authorization pathway allows vaccines to be authorized for use in a public health emergency before the full approval process is complete. Deviating from the standard, trusted EUA process could raise the likelihood of a subsequent reversal of the decision, which would risk undermining trust in the FDA right when we need it most. A short delay, then, is worth it: We have imperfect substitutes for vaccines, but there are no substitutes for trust in the FDA.
Of course, this decision inevitably comes with negative consequences. But there are things that the government and public health professionals can do to limit them, and potentially even come out ahead. First of all, it’s important to avoid the temptation to rein in the FDA. It should be allowed to perform its regulatory activities unencumbered. Plenty of FDA announcements are bad news. But when it comes to the FDA, transparency is not only more important than messaging, transparency is the message.
Instead, the government and health professionals should educate the public about the FDA to help explain the reasoning behind its actions. The FDA’s reputation for reliably acting with “an abundance of caution” makes it easier to interpret its decisions: Authorizations and approvals should inspire high levels of confidence, and pauses for data review may uncover little cause for concern. Vaccination programs must work to keep vaccination rates rising by rescheduling appointments and improving vaccination access for those affected by the pause. Lastly, the government and public health professionals must immediately redouble their outreach efforts to counteract any increases in vaccine hesitancy. All three of these activities pay dividends beyond public health and far into the future, and are therefore well worth it.
Ultimately, all Americans benefit from having a responsive, rigorous, and trusted FDA. When we consider the big-picture perspective, it becomes clear that preserving and building trust in the system is much more important than preserving trust in any one vaccine.
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