Vinay Prasad FDA Vaccine Regulator Returns After Resignation

In a move raising eyebrows across the political spectrum, Dr. Vinay Prasad is returning as the FDA’s top vaccine regulator less than two weeks after resigning under intense public pressure. Prasad will once again lead the Center for Biologics Evaluation and Research (CBER) at the request of the U.S. Food and Drug Administration, confirmed by the Department of Health and Human Services (HHS).

HHS Communications Director Andrew Nixon defended the decision, telling The Defender:

“Neither the White House nor HHS will allow the fake news media to distract from the critical work the FDA is carrying out under the Trump administration.”

This rapid rehiring follows a politically charged storm over Prasad’s handling of a controversial gene therapy withdrawal — and the backlash from both biotech insiders and public health critics.

Why Prasad Resigned in the First Place

On July 29, Dr. Prasad resigned after halting sales of Elevidys, a lucrative gene therapy for Duchenne muscular dystrophy manufactured by Sarepta Therapeutics. His decision came after the deaths of three trial participants.

FDA leadership met with Sarepta on July 18, instructing the company to stop clinical trials and shipments. Sarepta initially resisted but ceased distribution on July 22. The move drew sharp criticism from influential outlets and advocacy groups, many of which have close ties to the pharmaceutical industry.

Notably:

The Wall Street Journal, Real Clear Health, and STAT News published editorials condemning Prasad’s pause on Elevidys.
Investigative journalist Paul D. Thacker reported that some parent advocacy groups opposing the pause were funded by Sarepta itself.

The FDA lifted the temporary hold on July 28 — one day before Prasad’s resignation — allowing limited distribution to certain patients.

Stock Market Reaction Tells the Story

When Prasad stepped down, biotech stocks surged. When news broke of his return, those same stocks dipped sharply, according to Bloomberg. The market’s response underscores how closely pharmaceutical profits are tied to regulatory decisions — and why Prasad’s leadership is a flashpoint for Wall Street and Washington alike.

Political and Media Firestorm

Prasad’s resignation sparked a campaign from outspoken critics, including conservative commentator Laura Loomer, who called him a “progressive leftist saboteur” and urged President Donald Trump to fire him.

After news of his return, Loomer blasted the decision as “another egregious personnel decision” and vowed to intensify her investigations into the FDA and HHS, claiming she would expose “pay-for-play rot” and political bias in upcoming Senate confirmation hearings.

Prasad’s Track Record: Vaccine Skepticism and COVID-19 Policy

Prasad’s career prior to the FDA was marked by public dissent against mainstream COVID-19 policy:

Opposed masking toddlers during the pandemic.
Raised alarms about myocarditis risks in young men receiving mRNA vaccines.
Co-authored a framework limiting updated COVID-19 shots to high-risk individuals over 65 or those with significant health conditions.

Unlike his predecessor Peter Marks — who oversaw Operation Warp Speed and fast-tracked COVID-19 vaccines — Prasad advocated for randomized clinical trials with real-world outcomes before approving vaccines for healthy people aged 6 months to 64 years.

Why This Matters for Those Skeptical of the Vaccine

Prasad’s reappointment comes at a time when public trust in vaccine oversight is fractured. For many Americans, especially those skeptical of the rushed COVID-19 rollout, his willingness to pause a high-profit drug over safety concerns stands in stark contrast to an FDA often criticized as too cozy with Big Pharma.

His return suggests that, despite corporate pressure, there may still be internal voices at the FDA willing to challenge the pharmaceutical industry’s dominance over public health policy. However, whether this signals a meaningful shift or is merely political theater remains to be seen.

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Author: Sean Probber

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