The case for Mr. Biden’s booster program is shaky. Most doctors agree that the additional shot makes sense for older and immunocompromised people, who face a higher risk of serious illness if they suffer a breakthrough infection. Yet the data suggests and experts have argued that hardly any hospitalizations or deaths will be prevented by giving boosters to other groups like frontline workers, because their risk is so low to begin with. Still, health officials across the country report that people are clamoring for boosters, and according to data from the C.D.C., more than a million people have already gotten one — in many cases by lying about their vaccination status, experts say.
The administration’s misfire leaves little confidence in its ability to navigate a coming roster of crucial decisions — about whether to authorize shots for young children or boosters for those who received the Moderna or Johnson & Johnson vaccines.
It does not help that nearly nine months into Mr. Biden’s term, the F.D.A. still does not have a permanent commissioner. As both of Mr. Trump’s commissioners demonstrated, a permanent commissioner has a huge influence on the agency’s agenda and the tone and tenor of its work. Whether the F.D.A. kowtows to or resists political interference, how firm the agency is with the industries it regulates, what its priorities are in any given year — are all determined in large part by the person steering the ship. Mr. Biden has yet to even nominate someone for the job.
Dr. Woodcock has hardly inspired confidence in the meantime. Not only did she pre-empt and undermine her regulators by supporting Mr. Biden’s booster plan, but this year she also presided over the approval of a highly dubious Alzheimer’s medication, against the advice of her agency’s own advisory committee. That decision triggered a backlash and resignations, as well as an investigation.
It’s become common to say that the F.D.A. is moving too slowly, given the magnitude of the Covid crisis and that it should, for example, approve or authorize shots for children much more quickly than it has. But speed is not the agency’s biggest failing. In fact, given how underfunded and understaffed the agency is in normal times, one could argue that speed is not its fault at all. It takes real investment and sustained commitment for any agency to be fast and nimble in a crisis. The F.D.A. has had neither for many years now.
A much bigger problem is the agency’s lack of transparency. Regulators expanded and prolonged the pediatric clinical trials without any real explanation and in a manner that left even their supporters confused and uncertain. It’s difficult to know whether that decision was warranted without more information on why it was made in the first place.
It’s also difficult to say whether Mr. Biden’s latest booster plan will undercut his recent pledge to help vaccinate 70 percent of the world’s population by this time next year. Mr. Biden has pledged to donate more than a billion shots to that effort. But Politico reported that the push for boosters in the United States was motivated as much by concerns over vaccine supply as by worries about waning vaccine effectiveness.
