A year ago, before any covid vaccine had been authorized for use, former President Donald Trump all but promised that a shot would be available before Election Day. When Food and Drug Administration regulators suggested that he was mistaken, he accused them of deliberately delaying their authorizations in an attempt to influence the coming election and threatened to override them.
At least some segments of the public were outraged: It was not the first time Trump had interfered with the agency, and health officials warned that his careless remarks would undermine vaccine confidence. The FDA responded forcefully, tightening its review criteria and communicating directly with the public about the changes. The agency's commissioner, Dr. Stephen Hahn, engaged in a standoff with the president who appointed him, and in the end, public safety was placed above political expedience.
This year, it is President Joe Biden who has gotten ahead of the FDA, announcing a plan to make covid booster shots available to all vaccinated Americans long before the agency finished its evaluations of the nation's three authorized vaccines. Rather than push back against this maneuver, acting FDA Commissioner Dr. Janet Woodcock endorsed it. Two of the agency's top vaccine regulators resigned in protest, taking with them a wealth of knowledge and experience that will be both urgently needed and difficult to replace in the months ahead.
The kerfuffle has once again undermined an agency that is supposed to be the regulatory gold standard not just in the U.S. but around the world.
To be sure, the FDA is not the only entity grappling with confusion and contradiction. The world's largest vaccine makers say they will soon have enough shots to inoculate just about the entire global population, but they cannot seem to get those doses to the lower-income countries that need them most. The leaders of the world's richest countries, including the U.S., say they are committed to global vaccine equity and have collectively pledged to donate hundreds of millions of doses to lower-income countries. But it is not entirely clear how those countries' current or projected supplies measure up against their promises to share.
It would be good to know the extent to which any booster initiative will undermine the quest for global vaccine equity, but critics say it is almost impossible to determine how many more doses could immediately go to lower-income nations.
Ending the pandemic will require a string of carefully calibrated trade-offs: between vaccinating children in one country and higher-risk groups everywhere else, between giving boosters in wealthy nations and spreading vaccine abundance, between stockpiling and sharing. Most of those trade-offs will require a more functional regulatory apparatus than we have seen so far.
The FDA has determined that for the Pfizer vaccine, at least, boosters are warranted only for people older than 65, the immunocompromised and those whose work or living arrangements place them at higher risk of exposure. Biden and his team, including Woodcock, softened their booster messaging in response, agreeing to offer the extra shots only to people for whom the FDA has authorized them and insisting its plans were always contingent upon agency approval.
Meanwhile, the Centers for Disease Control and Prevention's advisory panel disagrees with the FDA's assessment and said boosters are not yet needed for people who face a higher risk of exposure but a low likelihood of severe illness. In yet another unusual move, the CDC's chief, Dr. Rochelle Walensky, has overruled her own advisory group and sided with the FDA.
The case for 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 front-line 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 CDC, more than 1 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 Biden's term, the FDA still does not have a permanent commissioner. As both of Trump's commissioners demonstrated, a permanent commissioner has a huge influence on the agency.. Whether the FDA 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. Biden has yet to even nominate someone for the job.
Woodcock has hardly inspired confidence in the meantime. Not only did she preempt and undermine her regulators by supporting 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.
It has become common to say that the FDA 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 FDA 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 is difficult to know whether that decision was warranted without more information on why it was made in the first place.
It is also difficult to say whether Biden's latest booster plan will undercut his recent pledge to help vaccinate 70% of the world's population by this time next year. But Politico reported that the push for boosters in the U.S. was motivated as much by concerns over vaccine supply as by worries about waning vaccine effectiveness.
World leaders and U.S. regulators know the best way to prevent serious illness and death and to end the pandemic altogether: by getting shots in arms, especially the arms of those who have not had any shots at all. Now they need to more forcefully act on that knowledge.