Why Should I Trust You? Special Ep: What the Heck Just Happened with Moderna & the FDA? A Conversation w The Atlantic's Ben Mazer
Feb 21, 2026
Ben Mazer, surgical pathologist and Atlantic health journalist, breaks down the Moderna–FDA flap. He walks through trial design controversies, why the control arm mattered, and whether stricter evidence standards or politics drove the reversal. He also weighs mRNA’s strengths and limits for flu, potential chilling effects on developers, and how regulatory choices shape public trust.
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Why Moderna's Application Was Initially Rejected
- Moderna received a refusal-to-file because its pivotal trial compared the mRNA vaccine to a standard-dose shot, not the higher-dose option favored for seniors.
- The FDA said that made the study not "adequate and well-controlled," which halted review until the agency reversed course.
The Problem With Inferior Control Arms
- Vinay Prasad and others target inferior control arms as a systemic problem that makes new drugs look better than they are.
- This practice has been a longtime issue in oncology and shaped Prasad's regulatory agenda.
FDA Approves; Clinicians Decide Use
- Remember the FDA's role: approve safe and effective options, not set treatment guidelines or insurance coverage.
- Doctors, guideline bodies, and insurers should decide real-world use and payment, not the FDA alone.