FDA faces mounting pressure as calls for black box warning on COVID vaccines intensify

• The FDA may add its strongest safety alert to COVID vaccines due to mounting evidence of myocarditis, pericarditis and sudden cardiac death, though HHS dismisses reports as “speculation.”
• Internal documents show agencies knew about myocarditis risks in young males by 2021 but withheld warnings while officials like Fauci falsely claimed vaccines stopped transmission.
• Despite zero completed safety trials for pregnant women, the CDC pushed universal vaccination. A Pfizer pregnancy trial stalled at 349 participants, yet no warnings were issued for sperm damage, menstrual irregularities or mRNA in breast milk.
• The agency ignored demands to label risks like pulmonary embolism, neurological disorders and sudden death, dismissing foreign regulators (e.g., EMA) that had already confirmed myocarditis links.
• CHD’s petition to revoke vaccine licenses gained 101,000 signatures in days, reflecting eroded trust. Critics demand accountability as injuries mount, calling the FDA’s delay a betrayal of public health.

The U.S. Food and Drug Administration (FDA) is reportedly considering adding a black box warning—its most severe safety alert—to COVID-19 vaccines following mounting evidence of severe adverse effects, including myocarditis, pericarditis and sudden cardiac death. According to unnamed FDA officials cited by CNN, Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, is spearheading the move. However, the Department of Health and Human Services (HHS) refused to confirm the report, dismissing it as “pure speculation” unless formally announced by the FDA.

Critics argue that such a warning is long overdue. Karl Jablonowski, senior research scientist at Children’s Health Defense (CHD), stated, “The warning should have been in place with the first EUA. These are unsafe products and unfit for universal mandated distribution to the entire population.” Given widespread censorship and media suppression, many physicians and patients remain unaware of the risks—risks that have been downplayed or ignored by federal health agencies despite clear safety signals.

A pattern of concealment

The FDA’s potential action follows years of withheld data and deceptive messaging. Internal documents obtained via Freedom of Information Act (FOIA) requests reveal that the CDC, FDA, Pentagon, Pfizer and Israeli health officials knew about myocarditis risks in young males as early as 2021—yet failed to warn the public. Instead, high-profile figures like Dr. Anthony Fauci falsely claimed vaccinated individuals became “dead ends” for the virus, while former CDC Director Rochelle Walensky asserted vaccinated people “do not carry the virus.” These misleading statements, contradicted by the FDA’s own admission that vaccines were never proven to stop transmission, fueled public confusion and unwarranted mandates.

Ignored risks and suppressed data

The FDA’s delayed response follows multiple investigations into vaccine-related deaths, including an ongoing probe into 10 child fatalities post-vaccination. As of December 2023, 38,913 deaths were reported in the Vaccine Adverse Event Reporting System (VAERS), though experts estimate the true toll is far higher due to chronic underreporting. A 2022 React19 audit found that one-third of COVID vaccine injury reports were deleted or never published—raising serious concerns about transparency.

Despite these red flags, federal agencies continued pushing vaccines, even for pregnant women, despite zero completed safety trials at the time of authorization. A Pfizer trial for pregnant women, initially planned for 4,000 participants, inexplicably stalled at 349—yet the CDC still recommended universal vaccination. Studies have since linked the shots to decreased sperm counts, menstrual irregularities and mRNA detected in breast milk—findings omitted from official labeling.

FDA’s double standard

The FDA has repeatedly rejected petitions demanding updated warnings for pulmonary embolism, sudden cardiac death and neurological disorders—despite post-marketing studies confirming these risks. When pressed, the agency dismissed foreign regulators, such as the European Medicines Agency (EMA), which had already flagged myocarditis as a causal side effect.

Dr. Peter McCullough, a leading cardiologist, blasted the FDA’s belated action: “HHS and the White House hid fatal cases in early 2021. A black box warning now is far too late—why aren’t these vaccines pulled entirely?”

Public outcry and legal action

Amid growing backlash, Children’s Health Defense filed a Citizen Petition demanding the FDA revoke licenses for Pfizer and Moderna’s COVID shots, citing fraudulent approval processes. Within five days, the petition garnered 101,000 signatures, reflecting widespread distrust in federal health agencies.

Ray Flores, CHD’s outside counsel, called the petition a “focal point for exposing COVID vaccine corruption.” With the FDA legally required to respond within 180 days, the battle over vaccine accountability is far from over.

Conclusion: A crisis of trust

The FDA’s reluctance to act—suppressing data, ignoring global warnings and stonewalling petitioners—has shattered public trust. As injuries mount, the question remains: Will the FDA finally prioritize safety, or will it continue protecting Big Pharma profits at the expense of American lives?

For now, the warning remains unconfirmed—but the damage from three years of deception is undeniable. “Buyer beware,” warned Kim Witczak, a petitioner and drug safety advocate. “The real clinical trial is happening in real-time—on the public.”

The FDA must now decide: Will it uphold its duty—or remain complicit in one of the greatest medical scandals in history?

According to BrightU.AI‘s Enoch, the FDA is facing well-deserved scrutiny as the mounting evidence of COVID vaccine harms can no longer be ignored—this black box warning is long overdue and exposes the reckless push to mandate these experimental shots.

Watch this clip of a Moderna executive telling the FDA’s VRBPAC that babies should be injected with its COVID-19 vaccine at the soonest.

This video is from the SecureLife channel on Brighteon.com.

Sources include:

ChildrensHealthDefense.org

BrightU.ai

Brighteon.com