‘Warp speed’ for vaccine ended with US regulators
Just after 6:30 GMT on Tuesday morning, a 90-year-old retired British shop clerk named Margaret Keenan became the first person to receive the Pfizer/ BioNTech coronavirus vaccine outside of a clinical trial.
This was a historic moment. A novel disease was first reported in the city of Wuhan, China, on Dec. 31, 2019. Not even 12 months later, a thoroughly vetted and highly effective vaccine was already being distributed. Just pause for a moment and savor that.
But Americans can be forgiven if their savoring is slightly bittersweet. The first dose of a vaccine developed by a U.S. company was administered to a Brit, while Americans are still waiting for it to become legal here. As Marty Makary of Johns Hopkins University put it, the United States had “Operation Warp Speed in developing vaccines but Operation Turtle Speed in reviewing the results.” Makary argues that the review should have taken hours, not weeks.
On Thursday, a Food and Drug Administration panel (finally!) convened to decide whether there’s enough evidence to give the vaccine an emergency use authorization. If all goes well, the agency could greenlight distribution as early as this weekend. But when a virus is spreading as rapidly as the novel coronavirus is, interrupting even a few transmission chains a few days earlier can mean a significant number of lives saved down the road. We have good reason demand all due speed — and to demand our government explain why
U.S. regulators couldn’t get the job done, when U.S. companies could.
Of course, regulators might answer that we need to go slowly, not least to demonstrate to the public that the authorities are taking great care to ascertain that the vaccine is safe. Economist Alex Tabarrok launched a broadside against this argument last week, saying, “There is no guarantee that the risk averse, fearful and scientifically illiterate will be convinced by extra FDA investigation and there is plenty of evidence that they won’t be.”
Unlike Tabarrok, I have some sympathy for this idea; ultimately, the FDA doesn’t just certify medical innovations, but manufactures a certain amount of trust in their safety, so people will actually use them. And we have never needed that trust more.
American faith in experts and institutions, at a low ebb generally, is particularly dire when it comes to the pharmaceutical industry, which placed last out of 20 industries in a 2019 Gallup poll. Long before the pandemic, many historically marginalized groups were deeply suspicious of the health- care system, and not entirely without reason. Even in the privileged suburbs, growing numbers of Americans began trusting strangers they met on Facebook over the experts who told them they should vaccinate their kids.
Nor can the government necessarily help by blessing the industry’s products, for the federal government ranks just above Big Pharma in Gallup’s survey. In both cases, roughly a quarter of the population viewed them positively.
This already shaky foundation has developed even deeper cracks over the past year — thanks to allegedly impartial experts who condemned public gatherings, then made exceptions for mass protests; to politicians who urged their constituents to be careful while partying on the sly; to a president who turned basic pandemic precautions into a political litmus test; to public health authorities who first said masks didn’t work, and then said everyone should wear them; to a thousand other such incidents I don’t have space to name.
Often these were sincere attempts to manage public fears — keeping terrified citizens from hoarding masks that health- care workers desperately needed; positioning public health as a sympathetic ally of the outraged communities that were pouring into the streets, in order to persuade them to do it more safely. Nonetheless, such compromises made experts and officials seem hypocritical, their edicts arbitrary. The FDA’s defenders are right that we desperately need to repair that damage.
But to endorse a “slow and steady” approach, it’s not enough to prove that a dangerous lack of civic trust ails our republic. We’d also need to establish that deliberation-bordering- on-lassitude is a useful treatment, with minimal unwanted side effects.
And here I agree with Tabarrok. The vaccine skeptics I encounter in the wild aren’t paying close attention to the FDA’s schedule. They’re conservatives who’ve become reflexively suspicious of any measures the left proposes to control the pandemic. Or they’re less political folks with normal human fears about injecting things into their bodies. Their reaction would have been exactly the same if we’d approved this vaccine a month ago — or a year from now.