FDA's Straight Shooter: Don't Bring Crappy Data To A Gunfight
Inside Vinay Prasad's standoff with Moderna
For years the Food and Drug Administration has handed down shocking decision after shocking decision, always in the same direction: The approval of Alzheimer’s drugs that are balanced precariously on a mountain of fraudulent papers and that sometimes make your brain explode; the approval of OxyContin for 11-year-olds; the approval of COVID-19 booster shots in healthy young people in order to please the political science majors in the White House.
But there’s a new sheriff in town, and he’s made a lot of powerful enemies already reining in a lawless pharmaceutical industry.
“Vinay Prasad’s Vaccine Kill Shot,” the Wall Street Journal editorial board shrieked on Feb. 11, referring to the decision by the FDA’s new chief vaccine regulator to send back a study of Moderna’s mRNA flu vaccine with a grade of incomplete, saying it does not meet the standards of an “adequate and well-controlled” study.
Prasad, the head of FDA’s Center for Biologics Evaluation and Research, personally signed a Feb. 3 “refuse to file,” a formal refusal to review Moderna’s clinical trial — a regulatory middle finger.
“I feel like the word ‘surprised’ gets used a lot in the company communications we see,” said Drew Armstrong, executive editor of the pharma trade publication Endpoints News, on a podcast following the decision.
But the FDA makes shocking decisions all the time. What’s novel this time — provoking an unusual rebuke by Moderna and a media meltdown — is that the decision defies pharma influence rather than capitulating to it.
Last year, Prasad was installed at FDA, then UN-installed, then RE-installed after a dizzying smear campaign, aided in large part by the Journal, which called him a “Bernie Sanders Acolyte in MAHA Drag.” No one has definitively identified the roots of that smear campaign, but it coincided with Prasad’s crackdown on an expensive gene therapy after the deaths of several young patients. Rather than humbling Prasad, the episode and his triumphal return to FDA seem to have emboldened him. The Journal revived the smears again in its Feb. 11 editorial, likening his action on the Moderna flu vaccine to a “drive-by shooting.”
His bloody crime?
Per a company press release, FDA repeatedly flagged that Moderna’s clinical trial may inflate the benefit of its flu vaccine in adults 65 and older, the population most at risk of getting very sick from flu, by comparing it to a vaccine inferior to the standard of care.
According to the Centers for Disease Control and Prevention (CDC) committee that sets U.S. vaccine policy, individuals 65 years old or older should receive one of the three following flu vaccines: Fluzone High-Dose, Flublok or Fluad. But Moderna compared its vaccine against a flu vaccine not on the committee’s list, Fluarix. A closer inspection of the label of Fluarix shows that its efficacy drops off dramatically with age to just 14 percent efficacy from ages 50 to 64. The wide confidence interval for that 14 percent figure includes the possibility that the vaccine may not work at all in older individuals.
It’s not clear whether Moderna informed participants in the control group that better options existed, raising ethical concerns.
Moderna did not respond to a request for comment.
