President Biden declared last week that a new Covid booster shot “works” and is “necessary.” He said he would ask Congress to fund it and “it will likely be recommended that everybody get it no matter whether they’ve gotten it before.” Is this our new drug-approval process? There are no human-outcomes data on this new shot, which the Food and Drug Administration is expected to approve in the next two weeks.

Undermining the normal scientific and regulatory process erodes public trust. Last fall the administration approved and recommended a novel Covid bivalent booster with no human data. Only 20.5% of American adults took it, and some were compelled to do so by employers or schools. The recommendation was based on mouse data and failed to recognize the 100,000-fold risk difference between a healthy young person and a comorbid elderly adult. The government paid $4.9 billion for 171 million doses, the vast majority of which went to waste.

It’s possible a new booster will mitigate the severity of Covid infection, but the variants it targets are fleeting. Press releases from Pfizer, Moderna and Novavax state that their new boosters work on the two dominant variants in circulation today, EG.5 and FL.1.51. But we don’t know which variant will be dominant later this winter. A newer variant, for which the novel booster vaccine has unknown efficacy, has already been identified in Michigan and outside the U.S.

[Data? DATA? We don’t need no stinkin’ DATA! ~ Beege]