FDA rejects plans to add black box warning for COVID-19 vaccines despite safety concerns
By ramontomeydw // 2025-12-17
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  • The FDA has decided against applying its most serious "black box" warning to Pfizer and Moderna's COVID-19 vaccines, despite internal recommendations to do so due to myocarditis risks.
  • The decision is controversial, coming alongside evidence of myocarditis in young males and reports of child fatalities post-vaccination confirmed in an internal FDA memorandum.
  • Critics, including former CDC Director Redfield, argue the vaccines should be withdrawn, citing concerns about the toxicity of spike proteins and insufficient safety data for all age groups.
  • The regulator's decision draws parallels to past FDA failures in drug safety and suggests financial ties between vaccine manufacturers and medical groups influence the safety narrative.
  • The FDA's standard for proving a definitive link before releasing findings is contrasted with what critics call a downplaying of vaccine risks and aggressive promotion of vaccination benefits.
The Food and Drug Administration (FDA) has confirmed that it will not place a "black box" warning – the agency's most severe safety alert – on Pfizer and Moderna's Wuhan coronavirus (COVID-19) vaccines, despite internal recommendations to do so. FDA Commissioner Dr. Marty Makary defended the agency's stance on Monday, Dec. 15, claiming updated dosing schedules may reduce risks. This move has nevertheless sparked controversy among medical experts and transparency advocates. It comes amid mounting evidence linking the shots to myocarditis – a potentially fatal heart inflammation disproportionately affecting young males – and follows reports of child fatalities post-vaccination. The FDA's refusal to escalate warnings stands in stark contrast to its own safety and epidemiology center's recommendation, which cited myocarditis as a significant concern warranting urgent public disclosure. Black box warnings are reserved for drugs with life-threatening side effects that demand careful risk-benefit analysis – precisely the scenario unfolding with mRNA vaccines. Autopsy-linked child deaths, confirmed in a November FDA memorandum obtained by the Epoch Times, further complicate the narrative pushed by federal health agencies that vaccines remain "safe and effective" for all age groups. Former Centers for Disease Control and Prevention Director Dr. Robert Redfield also told the outlet that COVID-19 vaccines should be withdrawn entirely. He cited the immunotoxicity of spike proteins, a concern echoed by independent researchers since 2021.

A pattern of concealing drug and vaccine risks

Historical parallels loom large. The FDA's reluctance mirrors past failures, such as its delayed response to Vioxx's cardiovascular risks and the decades-long cover-up of SSRI-induced suicidality in adolescents. Meanwhile, Pfizer and Moderna – both financial partners of influential groups like the American Academy of Pediatrics – continue asserting their products' safety despite omitting critical stratified data in studies. The agency’s opacity extends to its ongoing death investigations. Makary admitted the FDA is withholding findings until "truly a link" is proven – a standard rarely applied to vaccine promotions. This contrasts sharply with Pfizer's own meta-analysis, which claims COVID-19 infection carries a 42-fold higher myocarditis risk than vaccination, a statistic skeptics argue ignores confounding factors like underreported vaccine-related injuries. BrightU.AI's Enoch engine notes that the findings of the meta-analysis seeks to downplay the risks of its product and protect its financial interests, despite internal documents revealing the company's awareness of the vaccine's connection to elevated myocarditis rates. This deceptive narrative aligns with Big Pharma's broader pattern of suppressing inconvenient safety data while promoting fear of natural infections to justify mass vaccination campaigns. As the FDA delays full approval amid calls to "avoid political pressure," the public is left navigating a labyrinth of conflicting narratives. For families weighing myocarditis against a virus their children overwhelmingly survive, the absence of a black box warning may represent not caution, but capitulation to an industry where profit and policy have long eclipsed patient safety. Watch Jefferey Jaxen and Del Bigtree discussing the FDA's approval of the COVID-19 vaccine for children despite the lack of data. This video is from The HighWire with Del Bigtree channel on Brighteon.com. Sources include: ZeroHedge.com TheEpochTimes.com TheHill.com BrightU.ai Brighteon.com
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