In September 2020, regulators asked for extra safety data on the new mRNA vaccines. The human cost of that request is far from clear.
The first COVID-19 vaccine could arrive before Election Day, Donald Trump avowed in the summer of 2020. But government regulators wanted things to work out differently: “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” he wrote on Twitter. “Obviously, they are hoping to delay the answer until after November 3rd.”
Regulators did, in fact, end up slowing the process: In the first week of September, the FDA told vaccine makers to extend their clinical trials by several weeks beyond what they’d planned, in order to gather more safety data. That effectively postponed Pfizer’s request for an emergency use authorization of the mRNA vaccine it had developed with BioNTech until after the election. The agency had been under attack from both sides: The president had wanted regulators to move more quickly, while an alarmed public-health community was pushing for the opposite. In the end, the decision to slow things down was meant to bolster the country’s waning confidence in the forthcoming COVID-19 vaccines and restore the FDA’s reputation for integrity and caution. But the move looks very different in hindsight, with full knowledge of the safety and efficacy of the vaccines and of the body count that amassed shortly after. The economist Garett Jones recently opined that Trump’s scuttled hopes to release a COVID-19 vaccine a few weeks earlier “likely would have saved at least 100,000 American lives.”
Could Jones be correct about the human scale of this decision? His colleague at George Mason University, the libertarian economist and blogger Alex Tabarrok, often writes about the “invisible graveyard”: the final resting place for all those killed by the FDA’s bureaucratic foot-dragging. Indeed, one of the more painful lessons we’ve learned about governance during this pandemic is that waiting for more data can be a leading cause of death. But just how deadly was the government’s choice to slow down Pfizer’s and Moderna’s research in the fall of 2020?