A reckoning is underway at the FDA

An unprecedented admission inside the FDA has shattered years of government assurances about Covid vaccine safety — and may signal the most consequential overhaul of vaccine oversight yet.

For months, a quiet battle has been unfolding inside the U.S. Food and Drug Administration (FDA).

It began with an analysis of child deaths after Covid vaccination, followed by strategic leaks to major media outlets, and has now erupted into the open with a memo from the regulator’s own vaccine chief.

In September, it was reported that FDA officials had privately investigated 25 paediatric deaths following Covid vaccination — the first systematic review of such cases since the rollout began.

The findings were meant to be presented to the CDC’s Advisory Committee on Immunization Practices (ACIP). But the presentation never came. The meeting passed without a word. Something had happened behind closed doors.

Now we know what.

On 13 November 2025, STAT published an extraordinary insider account describing a tense internal meeting in which FDA scientist Dr Tracy Beth Høeg presented evidence of young people who had died after Covid vaccination.

According to STAT, her findings triggered pushback from career FDA regulators who feared the implications of acknowledging fatal cases.

And now comes the explosive memo from FDA vaccine chief Dr Vinay Prasad, confirming — for the first time — that U.S. regulators have formally attributed at least 10 of these children’s deaths to Covid vaccination.

Prasad called it “a profound revelation” with far-reaching implications for American vaccine policy, warning that the true number is “certainly an underestimate.”

Here, I’ll take you through the memo, the leaks, the internal rebellion at FDA, and what this means — not just for Covid vaccines, but for all vaccine approvals going forward.

This story marks a turning point in U.S. vaccine regulation.