FDA May Slap COVID Vaccines With Black Box Warning, CNN Reports

Is it too little too late?

This article originally appeared on The Defender and was republished with permission.

Guest post by Brenda Baletti, Ph.D.

Black box warnings, also called “boxed” warnings, are the FDA’s most serious warning label, used to indicate that a drug is associated with a serious hazard, often including death or life-threatening reactions. COVID-19 vaccine critics told The Defender the warning comes too late, and that the shots should be pulled from the market.

The U.S. Food and Drug Administration (FDA) may add a “black box” warning to the COVID-19 vaccines, CNN reported today.

CNN cited unnamed FDA officials, who said that Dr. Vinay Prasad, chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, is overseeing the move to add the warnings.

The U.S. Department of Health and Human Services (HHS) declined to confirm the CNN report. “Unless the FDA announces it, any claim about what it will do is pure speculation,” HHS spokesperson Andrew Nixon said.

CNN said the officials didn’t provide specifics, including when the warnings would be issued, which side effects would be named, whether they would apply to all people who may take the drug, if they would be specific to the COVID-19 vaccines, or could refer to all mRNA technology.

“The warning should have been in place with the first EUA,” emergency use authorization, said Children’s Health Defense (CHD) Senior Research Scientist Karl Jablonowski. “These are unsafe products and unfit for universal mandated distribution to the entire population age 6 months and older — including during pregnancy.”

“Because of the censorship of science and media echo chambers, a black box warning may be the first time a physician or patient reads of a potential for harm, and a lot of harm has manifested from these shots,” he added.

Black box warnings, also called “boxed” warnings, are the FDA’s most serious warning label, used to indicate that a drug is associated with a serious hazard, often including death or life-threatening reactions.

For example, some opioids have boxed warnings for addiction, overdose and death. Several antidepressants carry a boxed warning because they are linked to suicidality in young people.

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Boxed warning speculation follows recent probes into vaccine safety

The report comes days after the FDA announced it is expanding its probe into COVID-19 vaccine-related deaths to adults, after initially confirming that the agency was investigating the deaths of 10 children who died after receiving the shot.

In September, the FDA initiated an “intense investigation” into the deaths of children who received the COVID-19 vaccine. The investigation drew from reports filed in the Vaccine Adverse Event Reporting System (VAERS), a surveillance system jointly run by the FDA and the Centers for Disease Control and Prevention (CDC).

As of Dec. 5, there were 38,913 reports of deaths following COVID-19 vaccines filed in VAERS among all age groups, according to OpenVAERS. More recent numbers are not publicly available.

However, the actual number of deaths is likely much higher. VAERS historically has been shown to report less than 1% of all adverse events.

A 2022 audit by React19, an organization advocating on behalf of COVID-19 vaccine injury victims and their families, found that 1 in 3 COVID-19 vaccine adverse event reports in VAERS were not posted publicly or were deleted.

In April, the FDA issued letters to Pfizer and Moderna, informing them they must revise their COVID-19 vaccine labels to include more detailed warnings about the risks of heart damage, including myocarditis.

The FDA told vaccine makers in May they must expand the age group they say is at risk for vaccine-related myocarditis and pericarditis, and warn that myocardial injury can be lasting among those who suffer it, the agency said.

The warnings mandated at that time were limited to those adverse events.

Is boxed warning too little too late?

After a leaked memo confirmed that the FDA was investigating child deaths associated with the COVID-19 vaccine, former FDA officials denounced the claims and said the FDA had responded to safety concerns with the vaccine as they arose.

However, Freedom of Information Act requests by CHD and others have shown that HHS officials under the Biden administration avoided issuing a formal warning to the American public — ignoring safety signals indicating the COVID-19 vaccines could cause myocarditis and pericarditis, especially in young men.

Well before the public health agencies informed the public of the possible risk, the CDC, FDA, U.S. Department of Defense, Pfizer and the Israeli Ministry of Health had documented evidence of myocarditis shortly after vaccination, predominantly in 16- to 24-year-old males. However, they didn’t publicly share that information.

They also ignored warnings in VAERS, documents showed.

Earlier this month, FDA Commissioner Marty Makary acknowledged that the agency sat on the data under his predecessor.

Dr. Peter McCullough, a cardiologist who sounded the alarm early on about the risks of myocarditis and pericarditis from the vaccines, said in an email to The Defender that adding a boxed warning to the shots now is “far too late.”

McCullough said:

“HHS and the White House had fatal cases reported to them in early 2021 and worked to hide the evidence from the public. This was revealed in the May 21, 2025, US Senate Hearing by the Homeland Security and Governmental Affairs, Permanent Subcommittee on Investigations led by Senator Ron Johnson.

“‘The Corruption of Science and Federal Health Agencies: How Health Officials Downplayed and Hid Myocarditis and Other Adverse Events Associated with the COVID-19 Vaccines’ generated a report that was ignored by the current FDA for over six months!

“The public should be asking, why the change now? More importantly, why aren’t all COVID-19 vaccines pulled from the market to protect the public from more fatal injuries?”

For years, scientists, researchers and members of the public have been calling on the FDA to pull the shots from the market as evidence that the vaccines are potentially harmful continues to grow.

Jablonowski said adding the warning flags a risk, but still implies the vaccines are effective.

“A good-faith review of the evidence hinges upon good-faith collection of that evidence,” Jablonowski said. “A black box warning does not infer a lack of efficacy; if anything, it is a testament to it. A seriously hazardous product that is of no use to anyone would be pulled. A seriously hazardous product with still a perceived efficacy would obtain the warning.”

Petition asking FDA to revoke Pfizer, Moderna COVID vaccine licenses garners almost 101,000 signatures in 5 days

At press time, nearly 101,000 comments had been submitted to the FDA, asking the agency to revoke the licenses for the “fully approved” Pfizer and Moderna COVID-19 vaccines.

Children’s Health Defense filed the Citizen Petition on Monday.

The petition alleges the FDA granted the licenses without requiring the manufacturers to meet the legal standards that typically govern licensed vaccines.

An HHS spokesperson confirmed that the FDA is reviewing the petition and that the agency will respond directly to CHD. Meanwhile, CHD urged the public to comment on the petition.

The petition asks Makary to determine that the two mRNA vaccines — Comirnaty and Spikevax — are misbranded and adulterated.

A Citizen Petition is a formal request to the agency to take regulatory action. Citizen Petitions, typically submitted by an organization, require extensive documentation of the issue and the legal basis for the claim.

The FDA must respond to the petition within 180 days, although the agency may extend that timeline.

CHD is urging the public, including healthcare workers, parents and military members, to submit comments on the petition, sharing their thoughts and experiences with the COVID-19 vaccines.

Attorney Ray Flores, outside counsel to CHD and one of the petition’s signatories, said the petition should “become the focal point for exposing COVID-19 vaccines.”

Related articles in The Defender

• Exclusive: New Evidence FDA, CDC Hid Early Data on Myocarditis Spurs Questions of ‘Criminal Coverup’

• CHD Asks FDA to Revoke COVID Vaccine Licenses, Calls on Public to Submit ‘Hundreds of Thousands’ of Comments

• Pfizer, Moderna Must Add Stronger Warnings About Possible Heart Damage From COVID Vaccines, FDA Says

• CHD Scientists Call For Investigation of CDC and FDA Suppression of Evidence Linking COVID Vaccines and Myocarditis

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