Jul 16, 2025
Dr. Vinay Prasad, FDA's Chief Medical and Scientific Officer, and CBER Director, addresses the recent New York Times article about his decision memo on COVID-19 vaccine approvals.
Title Options:
“FDA Official Admits to Overriding Reviewers: Here’s Why”
“Vinay Prasad Speaks Out: What Really Happened Behind Spikevax Kids Approval”
“My Memo: Why I Disagreed on Approving COVID Vaccine for Healthy Kids”
“Media Got It Right—Sort Of: An FDA Leader Walks Through the Vaccine Decision”
“When Science Disagrees: Internal Debate Behind Pediatric COVID‑19 Vaccine Approval”
Bullet‑Point Summary:
Prasad responds to NYT article titled “Top FDA Official Overrode Scientists”—confirms it was him.
Emphasizes respectful internal scientific debate; disagreement doesn’t imply wrongdoing.
Reading from his decisional memo: concluded that net benefit for healthy children was not certain, while risk‑group children approval was supported.
Key rationales: very low COVID severity in healthy kids; absence of randomized trials showing clinical benefit; limitations of surrogate endpoints like antibody levels.
Highlights unknown long‑term risks of mRNA vaccines.
Framework demands RCT data for healthy individuals—but allows use in high‑risk children.
Notes very low uptake among healthy kids (~<7%) in U.S.—no European nation recommends child vaccination.
Recalls controversies over J&J/AZ clotting risks and the decision not to pause earlier.
Also criticizes changing of Moderna approval’s interim analysis plan from 32 to 64 events, delaying transparency until post‑election—possibly political rather than scientific.
Emphasizes commitment to high scientific standards and preserving public trust.
Advocates randomized trials and proper benefit‑risk assessments moving forward.
Let me know if you'd like this formatted into a Substack post, video description, or article.
Transcript (punctuated/cleaned, preserving word order):
Now, I want to talk about something that I read in The New York Times.
I saw something headlined “Top FDA Official Overrode Scientists on COVID‑19 Shots.” I thought to myself, who the heck did this? It sounded really bad. I didn’t know about it. But then I read further—apparently I did it. It was me. Okay then.
So I want to walk through exactly what I’ve written on this topic because I think it’s worth discussing. One narrative the media portrays is that many vaccine reviewers had one point of view and I alone had another. Truth is, we may have some small disagreements—others may agree with me more. We all have slightly different viewpoints, informed by science and evidence. I respect both those who agree and those who disagree. It’s fine to have small disagreements on contentious topics.
I’ll read aloud from the decisional memo for the recent Spikevax kids approval so you can see why I wrote it—in my own voice.
First, thank you to David Kaslow for teaching me how to use the digital signature—very helpful. This memo explains CBER’s decision on the Moderna submission. I’ve read the supplemental review team’s recommendations, sponsor data, and peer-reviewed literature. The team did a commendable job—but I feel differently on certain issues, and reached the conclusion I describe below.
The question: is there substantial certainty of net clinical benefit—do benefits outweigh harms of vaccinating healthy children with mRNA vaccines? Our office’s answer: no—for healthy kids. For kids with risk factors: yes. Here’s why:
COVID‑19 severe disease, hospitalization, and death are extremely low in pediatric ages and have fallen. Rates are lower in healthy kids than those with risk factors, though CDC data don’t give specific rates for healthy kids. The manufacturer agreed to revised submission focused on kids with risk factors—and CBER approved that.
The applicant never showed reduction in severe COVID clinical outcomes in children in randomized trials. Such events are too rare; using observational studies with methodological limits—families self‑select, so controls may differ fundamentally.
No high‑quality data shows reduced long‑COVID or transmission, or fewer missed school days—these aren’t valid regulatory endpoints.
Many studies occurred in a pandemic context very different from today—population immunity and viral mutations change relevance. Vaccinating naturally immune kids may have uncertain benefit vs. risk.
Long term harms over decades are unknown—ignorant to claim they’re impossible.
Immunogenicity data (antibody titers) are surrogate endpoints—they correlate sometimes, but do not guarantee clinical benefit.
Our public framework (New England Journal of Medicine) emphasizes immunogenicity‑based approval for high‑risk groups, but requires randomized controlled trials for healthy individuals. Real‑world uptake among healthy kids is very low (less than 7%); no European peer nation advises healthy children to vaccinate—they’re outliers.
So under law, FDA can only approve products when benefits clearly outweigh harms. For healthy children, we lack substantial certainty. Sponsors are free to prove case through randomized trials. Meanwhile, products are available for high‑risk kids.
I want you to know I put this in. These reasons are the rationale. Disagreements aren’t about overriding 30 people—they’re about reasoned scientific debate. I respect my colleagues—and maybe we’ll influence each other.
We must uphold standards of evidence going forward. Post‑marketing commitments will require randomized trial data by spring. That can influence next actions. Benefit‑risk balance will evolve.
Other debates: J&J and AstraZeneca vaccine rare clotting (VITT), leading to program pauses. I felt strongly: wrong risk for a young woman when safer alternatives existed.
Statistical plan controversy: Pfizer’s trial originally planned interim analysis at 32 cases—likely mid‑October—to stop early under statistical threshold. But protocol changed to require 64 cases, delaying unblinding and ultimate release after the election. This change may reflect political pressure—not scientific reason—and might have cost tens of thousands of lives.
These controversies have been present from the start. My mission: effective products with strong safety evidence. We must avoid cherry‑picking (“Texas sharpshooter fallacy”). We must do the right thing for American public. We share core principles: science, evidence, controlled trials. I believe in those shared values.
Thank you—now handing over to Dr. Butler for operational notes.
