From Time:
White House COVID-19 response coordinator Dr. Ashish Jha expects the first Omicron-specific booster to be available in mid-September at the earliest, if the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) authorize and recommend the shot. In late August, both Pfizer-BioNTech and Moderna submitted requests to the FDA for authorization of their Omicron-specific boosters.
There’s a catch though: These boosters have been tested only on mice, not on humans. The article explains why some doctors think that it’s fair to extrapolate safety data from previous shots to this updated one. One doctor, however, gives an eye-popping dissent about the overall efficacy of this booster:
That has vaccine experts divided. Dr. Paul Offit, a member of the advisory committee, says this strategy makes him “uncomfortable” for several reasons. He notes that the data presented from Pfizer-BioNTech and Moderna in June involving their BA.1 booster shot, which focused on the levels of virus-fighting antibodies the vaccine generated, were underwhelming. “They showed that the neutralizing antibody titers were between 1.5- and two-fold greater against Omicron than levels induced by a booster of the ancestral vaccine,” he says. “I’d like to see clear evidence of dramatic increase in neutralizing antibodies, more dramatic than what we saw against BA.1, before launching a new product. We’re owed at least that.”
There was a libertarian and conservative vision of how the FDA should operate: more liberally, and faster please. They viewed the slow pace of the regulators as an impediment to discovery, innovation, and iteration. The development of Covid-19 vaccines seemed like a test run of that vision.
But there is another side to the story, which is trust. The faster that medicines are rolled out, and the less oversight they receive, the more room you have to make for public mistrust and doubt. A very short time ago, it was nearly unthinkable to approve new vaccines without human trials. Now, we live in a world where ongoing booster mandates in some localities would oblige citizens to take a medicine that was never tested on humans or forfeit their access to public accommodations.
The tradeoffs are becoming more obvious as you see the vast majority of Americans refusing to use the Covid-19 vaccines on their children, or to keep up with a uniquely quick booster schedule.
Speed or the ability to compel? This is the real tradeoff in public health during a pandemic.