Biden Waves Through Another Covid Booster

 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.

Advocates of the new Covid boosters point out that the annual flu shot gets approved without a randomized trial. But flu shots use a traditional vaccine platform that has withstood the test of time, and Covid vaccines have higher complication rates. The latter have a rate of serious adverse events as high as 1 in 556 doses, according to a study published last year in the journal Vaccine. They have also been found to cause myocarditis in young people at a rate six to 28 times the incidence after infection, according to a 2022 JAMA Cardiology study.

The novel Covid booster shot may be warranted for some high-risk patients. But pushing it hard for young and old alike without human-outcomes data makes a mockery of the scientific method and our regulatory process.

Mr. Makary is a professor at the Johns Hopkins School of Medicine and author of “The Price We Pay.”

https://www.wsj.com/articles/biden-waves-another-covid-shot-through-fda-human-outcomes-data-195731c0