The Wall Street Journal editorial board published a scathing takedown on Wednesday of President Donald Trump's top Food and Drug Administration vaccine regulator, Dr. Vinay Prasad, for his completely unsupported decision to reject Moderna's new mRNA flu vaccine.
Prasad has been the focus of controversy for a while, including from Trump's own supporters. Far-right influencer Laura Loomer briefly forced his resignation last year by slamming his rejections of drugs for rare diseases and his prior political support for Democrats, but he returned to his position just weeks later.
"This is arbitrary government at its worst," wrote the board. "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."
Prasad has claimed that Moderna's Phase 3 trial was not “adequate and well-controlled” — but this isn't true, the board noted.
"Moderna launched a global randomized controlled trial in September 2024 with 41,000 participants, half of whom received its vaccine," wrote the board. "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," since high-dose flu vaccines only go to people over 65 and aren't available in most European countries where the trial took place.
Prasad's random and arbitrary rejections of new drugs, wrote the board, "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," the board concluded. "But they also won’t appreciate a Trump regulator denying them access to new vaccines and treatments because he thinks he knows best."
