‘Pause’ on Johnson & Johnson Vaccine Reveals One Systemic Flaw Plaguing the FDA

Maybe Americans will finally realize the extent to which federal bureaucracy routinely stops potentially life-saving innovation in its tracks.

The US has lost nearly 570,000 souls to COVID-19-related deaths, according to official statistics, and that number continues to climb with each passing day. But the Food and Drug Administration just recommended a temporary halt on one of the potentially life-saving vaccines currently being distributed to millions.

The Johnson & Johnson vaccine was approved by the FDA under an emergency use authorization. Yet its use may now be halted.

“We are recommending a pause in the use of this vaccine out of an abundance of caution,” the FDA wrote in its statement. 

Many states and localities immediately responded to the news by canceling the scheduled distribution of the Johnson & Johnson vaccine.

Why They’re Blocking the Vaccine

Why is the FDA making this move? Because out of the more than 6.8 million Americans who have received the Johnson & Johnson vaccine, six experienced serious blood clotting problems, one of whom died.

“All six cases occurred in women ages 18 to 48, with symptoms developing six to 13 days after they received the shot,” CNBC reported. In a statement, Johnson & Johnson said that “no clear causal relationship” has been identified between the vaccine and the blood clots.

However, health officials are concerned because the type of blood clots involved can be life-threatening, and require different treatment than usual blood clotting. They hope that by taking time to study the possible consequence they can better inform doctors on what to look out for and further analyze any possible risk.

Putting the Risks in Context

Even if we assume the six reported cases of blood clotting are directly attributable to the vaccine, which has not been established, this is hardly an abnormal level of risk for common medications. 

For example, while the Johnson & Johnson vaccine has a one-in-a-million or less risk of blood clots based on current reports, common birth control prescription medication carries a 1 in 1,000 clotting risk. And such rare occurrences as being struck by lightning or killed by a comet are significantly more frequent than reported blood clotting from the Johnson & Johnson vaccine.

This sure seems like a minimal enough level of risk that people should be able to decide for themselves.

What Halting Johnson & Johnson Will Mean

Some experts have warned that the government’s decision to push Johnson & Johnson vaccination efforts to a halt will substantially hamper the rollout process, making it take longer for us to stop transmission of COVID-19.

“This will delay our vaccination efforts,” Dr. Kavita Patel, an NBC medical news analyst, warned on Tuesday. There are two other major vaccines, Pfizer and Moderna, that can eventually “pick up the slack,” but she said “it will take time” because “in the next one to three weeks, we just can’t substitute it.”

Additionally, there are benefits that the Johnson & Johnson vaccine has over the alternatives. 

Unlike Pfizer and Moderna, it uses old-school vaccination technology, not the newfangled MRNA technology that some are skeptical of. So, too, while the others require two appointments two weeks apart, the Johnson & Johnson vaccine is administered in a single dose—making it a huge logistical asset to the vaccination rollout.

The “halt” is a significant obstacle to getting vaccines to every American who wants one in a timely manner.

The FDA is Making a Really Bad Cost-and-Benefit Analysis

There are no easy solutions in public policy, only trade-offs. As a result, policymaking always requires a careful weighing of the costs and benefits. With this latest move, the FDA appears to have gotten the cost-benefit analysis all wrong. 

Setting the Johnson & Johnson vaccine aside, even for just a few weeks, could have serious consequences. More COVID-19 spread will occur than if vaccination was allowed to proceed, and it’s likely that some individuals who could have been protected will die in the interim.

“The benefits [of the vaccine] right now still outweigh potential risks because we have already lost over half a million people to coronavirus,” Dr. Janette Nesheiwat told Fox Business. “So for some groups, for some populations like those over the age of 65, the benefit of this vaccine is still going to outweigh any potential risk.”

“Also, it's important, again, to understand it's only six cases out of over six million that have been given,” the medical expert continued. 

As she rightfully notes, the costs of allowing the vaccine to be distributed are minute: Only 6 people out of millions have reported the negative side effect—and it’s not even proven to be directly connected. The harm mitigated by blocking the vaccine seems basically negligible.  

“The FDA is really being aggressive to ensure the safety of Americans,” Nesheiwat concluded. “But as it is right now, the benefits [of the vaccine] outweigh the risks.”

Interestingly, many policy analysts and media commentators from across the political spectrum have reached the same conclusion: The FDA clearly got this one wrong, and the consequences could be deadly.

It’s worth examining why the government failed here—and why it was predictable.

Unreasonable Risk Aversion is a Feature, Not a Bug, of the FDA

The FDA is systemically prone to this kind of institutional dysfunction because the incentives it faces reward excessive precaution. Essentially, it fails to accurately weigh costs and benefits because some costs, like bad publicity if they allow a harmful treatment, are directly borne by the FDA, while others, like the unseen lives that could have been saved, are not directly noticed and attributed to the FDA’s mistakes.

“The FDA has an incentive to delay the introduction of new drugs because approving a bad drug (Type I error) has more severe consequences for the FDA than does failing to approve a good drug (Type II error),” economics professor Alex Tabarrok has explained. “In the former case at least some victims are identifiable and the New York Times writes stories about them and how they died because the FDA failed. In the latter case, when the FDA fails to approve a good drug, people die but the bodies are buried in an invisible graveyard.”

Vindicating this theory, a comprehensive paper examining the FDA’s drug approval track record found that it is “often dramatically too conservative.”

The obtuse decision to block Americans from deciding for themselves whether to take the Johnson & Johnson vaccine is just the latest example of the FDA’s deadly incentive structure. The reasonable role for the FDA here would be to publicize all available information about the blood-clotting risks associated with the vaccine, and then let Americans make a decision based on their own cost-benefit analysis. 

The overriding of individual judgment by government officials huddled in Washington, DC only replaces effective decision-making with bureaucratic inertia. After this fiasco, maybe Americans will finally realize the extent to which our bloated federal government routinely stops potentially life-saving innovation in its tracks.