The decision by regulators to pause the Johnson & Johnson Covid-19 vaccine distribution was an intelligent one. So was the decision to resume it.
After careful examination of the scientific evidence, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) concluded the benefits outweighed the risks of restarting the Johnson & Johnson vaccine distribution in the United States.
What is most remarkable about this development is that European regulators led the way. Days before CDC vaccine advisers convened to make recommendations, the European Medicines Agency (EMA) had already concluded “the reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects.”
Perhaps even more surprising was how they did it. Using a cost-benefit analysis, while common practice in the U.S., marked a significant departure from Europe’s typical approach to regulatory decisions. Regulators in Europe tend to use the precautionary principle, a “better safe than sorry” approach that allows regulators to prohibit even the smallest of risks, no matter how large the potential benefit could be in other parts of our lives, economies, and societies.
A cost-benefit approach, on the other hand, provides decision-makers with information across several disciplines—epidemiology, toxicology, economics, psychology, etc.—on the probable costs and benefits of each potential action they may consider.
No vaccine is 100 percent effective and 100 percent safe. There are holes in every net. But using this more holistic approach, regulators in Europe and the U.S. quickly concluded the benefits of resuming the vaccine—fewer new cases, fewer hospitalizations, fewer deaths, and a quicker return to something resembling life as we knew it—far outweighed the risks. They determined the public should be provided with the facts, and allowed to decide for ourselves.
The agencies tasked with reviewing the Johnson & Johnson vaccine put on a master class in the responsible way to balance public health, scientific evidence, risk management, and common sense. We encourage regulators in every agency to apply the same cost-benefit approach to the important issues on each of their agendas.