Vinay Prasad’s Vaccine Kill Shot

It’s hard to recall a regulator who has done as much damage to medical innovation in as little time as Vinay Prasad. In his latest drive-by shooting, the leader of the Food and Drug Administration’s vaccine division rejected Moderna’s mRNA flu vaccine without even a cursory review. This is arbitrary government at its worst.

The FDA rarely refuses to review a drug or vaccine application. Our sources say the FDA has rejected only about 4% of applications without a review, typically when they are missing important information. That wasn’t the case with Moderna.

Dr. Prasad spiked Moderna’s flu vaccine because its Phase 3 trial was putatively not “adequate and well-controlled.” He quibbled that the control group in Moderna’s late-stage trial didn’t receive the “ best-available standard of care.” He decides what is “ best.”

Moderna launched a global randomized controlled trial in September 2024 with 41,000 participants, half of whom received its vaccine. The other half received a standard flu vaccine as a control. The FDA blessed its trial design, and agency staffers gave Moderna a thumbs up to apply for approval last August based on the results. Its vaccine was 27% more effective at preventing symptomatic cases of flu and 49% more effective against hospitalization than the standard flu vaccine.

Yet Dr. Prasad said Moderna should have used a high-dose flu vaccine as its control rather than a standard dose—though that wasn’t possible. In the U.S., high-dose flu vaccines are typically given only to seniors over age 65. They aren’t available in many European countries where Moderna conducted its trial. That’s in part because government-run health systems don’t want to pay for expensive high-dose vaccines. Irony alert: Dr. Prasad is a fan of single-payer healthcare.

Even so, Moderna’s vaccine proved equally effective as high-dose shots in a side-by-side comparison with a standard dose. One advantage of Moderna’s mRNA vaccines, however, is that they can be quickly adapted and manufactured to match new strains. The U. S. and world need better flu vaccines, which typically are about 40% effective. The flu can knock you out for a week or two, and studies show it increases the risk of stroke and heart attack by four-tofive fold.

Stat News reports that Dr. Prasad overruled staff who wanted to review Moderna’s application. Never mind that he and FDA Commissioner Marty Makary criticized their predecessors for overruling staff. Moving goal-posts and deep-sixing promising drugs is a pattern with Dr. Prasad.

The FDA in recent days has rejected Regenxbio’s gene therapy for the ultra-rare disease Hunter syndrome—which causes deformities and results in death in teenagers—despite the company following to a tee the agency’s guidance to win approval. This is the third rare disease drug Dr. Prasad has nixed in as many months for arbitrary reasons.

His management has caused morale at FDA to fall and resulted in an exodus of veteran staffers. It’s also discouraging investment in innovative vaccines and drugs. Moderna’s CEO Stéphane Bancel last month said “we do not foresee investing in new phase 3 studies” for vaccines because of the regulatory uncertainty. Is the White House paying attention?

Americans didn’t like the Biden Covid vaccine mandates. But they also won’t appreciate a Trump regulator denying them access to new vaccines and treatments because he thinks he knows best.