The case for Mr. Biden’s recall program is fragile. Most doctors agree that the extra bite makes sense for the elderly and immunocompromised, who are at a higher risk of serious illness if they suffer from a breakthrough infection. Still, the data suggests and experts have argued that few hospitalizations or deaths will be avoided by giving reminders to other groups like frontline workers because their risk is so low to begin with. Still, health officials across the country are reporting that people are calling for boosters, and according to CDC data, more than a million people have already received one – in many cases lying about their immunization status, according to experts.
The administration’s hiccup leaves little confidence in its ability to navigate an upcoming list of crucial decisions – whether to allow injections for young children or boosters for those who have received Moderna vaccines or Johnson & Johnson.
It doesn’t help that nearly nine months after Mr. Biden’s tenure began, the FDA still doesn’t have a permanent commissioner. As Mr. Trump’s two commissioners have demonstrated, a permanent commissioner has enormous influence over the agency’s agenda and the tone and content of its work. Whether the FDA bows down 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. who runs the ship. Mr. Biden has yet to even name someone for the job.
Dr Woodcock has hardly inspired confidence in the meantime. Not only has she beaten and undermined her regulators by backing Mr Biden’s recall plan, but this year she also presided over the approval of a highly questionable Alzheimer’s drug, against the advice of the own advisory board of his agency. The move sparked backlash and resignations, as well as an investigation.
It has become common to say that the FDA is moving too slowly, given the scale of the Covid crisis and that it should, for example, approve or authorize injections for children much faster than it does. did. But speed isn’t the agency’s biggest flaw. In fact, given the agency’s underfunding and understaffing in normal times, one could argue that the speed is not its fault at all. It takes a real investment and a sustained commitment for an agency to be quick and agile in the event of a crisis. The FDA hasn’t had either for many years.
A much bigger problem is the agency’s lack of transparency. Regulators have extended and prolonged pediatric clinical trials without any real explanation and in a way that has left even their supporters confused and uncertain. It is unclear whether this decision was justified without more information on why it was made in the first place.
It’s also difficult to say whether Mr Biden’s latest recall plan will undermine his recent promise to help immunize 70% of the world’s population by the same time next year. Mr. Biden has pledged to donate over a billion snapshots to this effort. But Politico reported that the call for recalls in the United States was motivated as much by concerns about the vaccine supply as it is by concerns about declining vaccine effectiveness.