Why You Should be Glad the FDA has Resumed Johnson & Johnson Vaccines

David Levine and Bruce Wydick

Americans—and the world—should cheer the government’s news Friday to lift the pause on the distribution of the Johnson & Johnson COVID-19 vaccine.  The decision will save many thousands of lives.

Some will bemoan the reversal by the Federal Drug Administration and the Centers for Disease Control—after all, haven’t three people died of blood clots that are clearly and directly linked to the vaccine?  But the problem is that most of us have poor judgment in weighing low-probability risks.  We tend to make decisions based on emotion rather than statistics, even when such decisions increase the probability of tragic events.  

Last week both of us did things that put the lives of our children at risk.  Bruce allowed his daughter to play in her high-school soccer game, ignoring the fact that approximately 1 out of every million high-school athletes die of sudden cardiac arrest every month.   David took an even greater risk.  He brought his son home from college to be vaccinated—even though about 10 Americans per million die in automobile accidents each month. 

Tragically, three people have died from blood clots that may have been linked to the Johnson & Johnson COVID vaccine, with which 8 million people have been vaccinated over the past two months.  Another seven also suffered from these serious clots, but are recovering.  As a result of these ten hospitalizations and three deaths, the FDA put a hold on J&J vaccinations.

But if the COVID death rate of 2020 continues, every million vaccinations will save roughly 1,700 lives this year.  A million J&J vaccines will probably save fewer than 1,700 lives next year because we have other vaccines, and we have already vaccinated those most at risk.  At the same time, the expected number of saved lives remains high because each vaccine helps protect those not vaccinated. 

We do not know which people will die of blood clots or COVID over the next year. But we do know that the death rate of those who fail to be vaccinated will be vastlyhigher than the rate of those who will die from vaccine-induced blood clots.  

The FDA suspended use of the J&J vaccine to investigate its link with blood clot cases and to seek better care for those with the rare clots.  Such pauses are standard FDA policy in normal times.  In normal times, vaccines keep the U.S. population safe from relatively rare diseases such as mumps and the measles.  Thus, a delay of a few weeks in a typical vaccine rarely leads to any deaths at all—or even illness. 

What the decision makers at the FDA and the CDC realized, however, is that the normal policy is not suited for a pandemic.  We are not living in “normal times.”  Millions remain jobless, we remain masked and distant, and thousands of Americans die from COVID each week. They rightfully concluded that what was most important was not understanding the medical link between blood clots and the vaccine, but understanding that more rapid vaccination will unambiguously save lives. 

A long delay in resuming the J&J vaccine while researchers thoroughly investigated the scientific details of the blood clot link would have been particularly dangerous.  Unlike the other two vaccines approved in the United States, the Pfizer and Moderna, the J&J vaccine requires only one dose and does not require special low-temperature refrigeration.  Thus, the J&J vaccine is best suited for mass inoculations – particularly for hard-to-reach populations, including overseas in low- and middle-income countries.

Importantly, because of its single dose and potential for rapid distribution, the J&J vaccine in particular will play a unique and critical role across the globe in reducing the opportunity for the COVID virus to mutate into more deadly variants.

Each preventable death is a tragedy.  At the same time, it would have been neither wise nor ethical to withhold a vaccine to save less than one statistical death per million, if in that same million people, the vaccine would have saved hundreds of others.

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