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Vinay Prasad Returns from FDA CBER to Critique Public-Health System

Vinay Prasad, former CBER director, reflects on his contentious FDA tenure, defends his vaccine decisions and calls for sweeping public-health reforms.

Vinay Prasad, a UCSF professor and former director of the FDA’s Center for Biologics Evaluation and Research, discusses his transition from outspoken COVID-era critic to insider and back again. He explains why he rejected Moderna’s mRNA flu-vaccine application, citing an inadequate control arm, and defends a leaked internal memo that listed at least ten children who died after COVID-19 vaccination, which he says was later down-scaled for political reasons.

Prasad describes the intense criticism he faced from one outlet, Laura Loomer and other commentators, and notes that his time at the agency convinced him that a more libertarian, consumer-driven model could improve drug access. He also critiques Anthony Fauci’s pandemic diaries, warns that AI-enabled drug discovery may outstrip current regulatory capacity, and calls for a more balanced, humble public-health system to regain public trust.

Why it matters

It reveals internal FDA disputes and proposes reforms that could reshape how vaccines and drugs are evaluated in the U.S.

In this story

public healthvaccine regulationFDA reformModerna flu vaccineCOVID-19 vaccine safetylibertarian consumer choiceAI in biotechAnthony Fauci diarieschild deaths memo
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