FDA: Causal Link Between COVID Vaccines & Deaths

For the first time in history, the U.S. Food and Drug Administration has officially stated - in writing - that COVID-19 vaccines caused deaths.
 
The admission comes in a leaked internal memo written by Dr. Vinay Prasad, Director of the FDA’s Center for Biologics Evaluation and Research - the office that approves every vaccine in America. This is the position of the agency’s top vaccine regulator.
 
Dr. Prasad wrote on November 29, 2025:
“For the first time, the U.S. F.D.A. will acknowledge that Covid-19 vaccines have killed American children.”
“These deaths are related to vaccination… kids aged 7 to 16 may be dead as a result of COVID vaccines.”
 
An initial review of 96 VAERS-reported pediatric deaths (2021–2024) concluded that at least 10 were caused by vaccine-induced myocarditis - using the explicit phrase “after and because of” the shots.
 
This marks the first time any major global regulator has unequivocally attributed fatalities to the mRNA COVID vaccines.
 
The memo has triggered worldwide coverage in The New York Times (which broke the story), Reuters, The Guardian, The Washington Post, CNN, AP, NBC, and BBC.

 
What the major outlets reported

• The New York Times (28 Nov - first to obtain the memo)
Described it as a “profound revelation” and quoted Prasad extensively. Detailed sweeping proposed reforms: mandatory placebo-controlled trials for all subgroups including children and pregnant women, an end to emergency-use shortcuts, larger studies before co-administration of vaccines, and a re-examination of annual flu-shot policy based on “low-quality evidence.” Highlighted the political context under HHS Secretary Robert F. Kennedy Jr. and noted the timing just before the CDC advisory meeting.
• Reuters (29 Nov)
Led with the human tragedy: “It is difficult to read cases where kids aged 7 to 16 may be dead as a result of COVID vaccines.” Quoted FDA Commissioner Marty Makary confirming on television: “There were, it appears, 10 deaths of children from the COVID shots.” Emphasised that the underlying data came from the Biden era and that Prasad is calling for tighter vaccine oversight.
• The Guardian (29 Nov)
Focused on expert backlash, quoting Paul Offit and others calling the memo “dangerous and irresponsible” without peer-reviewed data or autopsies. Reported the push for stricter vaccine approval protocols (including RCTs for children/pregnant women) but framed it as part of a broader political shift under the new administration.

Why this matters

After five years of “rare” or “coincidental,” an official FDA document now uses “caused,” “killed,” and “as a result of.”
 
The proposed reforms - real placebo trials, no rushed approvals, and renewed calls for systematic autopsies - represent the kind of transparency many have demanded since 2021.

The criticisms

The review is not peer-reviewed. No raw data, autopsies, ages, comorbidities, or brands have been released. Experts stress myocarditis from the virus is far more common and severe, and conclusions remain “debatable” without full evidence.
 
For context, AAP reports ~2,100 children have died of COVID since 2020, CDC ~1,071 (2020–2023). 

Bottom line

A leaked memo from the head of FDA vaccine regulation is still an official FDA position.
 
The word “caused” has finally entered the lexicon - five years late, but unmistakably.
The CDC advisory committee meets next week. React19 will be watching.

Sources:

The New York Times (28 Nov 2025) | Reuters (29 Nov 2025) | The Guardian (29 Nov 2025)