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The U.S. Food and Drug Administration (FDA) decided against putting a “black box” warning on COVID-19 mRNA vaccines, even though the agency acknowledged last month in a leaked memo that the shots killed at least 10 children.
FDA Commissioner Marty Makary said in an interview on Monday with Bloomberg Television that the agency has “no plans” to put a black box warning on COVID-19 vaccines, despite an internal recommendation to do so.
In the same interview, Makary confirmed that the FDA received reports during the Biden administration of death following COVID-19 vaccination, but the administration didn’t make those reports public.
Makary said he believes the reports should be made public — which is why the agency is investigating COVID-19 vaccine-related deaths in both kids and adults. “We wanted to make sure that, in fact, there was truly a link between the COVID shot and the death before we make it public.”
Makary’s comments to Bloomberg quelled rumors circulating since CNN last week reported that the agency intended to add black box warnings — the most serious warning the FDA issues — to COVID-19 vaccines.
The FDA’s Office of Surveillance and Epidemiology did formally recommend that a boxed warning be added to COVID-19 vaccines, Makary said. “But some of our scientists and leadership, like Dr. Vinay Prasad, said [the vaccine] may be different today than it was in the first year of COVID when the shot came out.”
Prasad, the agency’s top vaccine regulator, heads up the FDA Center for Biologics Evaluation and Research (CBER).
“When you have those two doses three months apart, that’s when you see the side effects go way up — like myocarditis in young people,” Makary said. “Now that it’s annual, you may not see that same prevalence. So we don’t want to extrapolate findings to today if it’s not transferable.”
That reasoning “sidesteps the core issue,” wrote medical investigative reporter Maryanne Demasi, Ph.D., in a Substack post. “Boxed warnings are triggered by documented harm — not by predictions about whether similar harm might recur under a modified dosing schedule,” she said.
Children’s Health Defense’s (CHD) Chief Scientific Officer Brian Hooker agreed. “The FDA is wrong, period. It is foolish to think that somehow two dangerous shots, when split apart, equate to one safe shot,” Hooker said.
Karl Jablonowski, Ph.D., CHD’s senior research scientist, said it’s true that the incidence of myocarditis increased “tremendously” in 2021 when people received a second dose soon after the first. “But for some young men, like Victor Simoes, who died of myocarditis shortly after his first dose, it only took one,” he said.
Just because the COVID-19 vaccines’ dosing frequency changed, the FDA is still obligated to publicly disclose the products’ earlier harms, Demasi said. “If deaths in children do not meet the FDA’s threshold for its strongest safety warning, it is difficult to see what would.”
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 Makary and Prasad “should show greater courage and leadership” by taking steps to protect people from further injury and death from the COVID-19 shots.
“Black box warnings should have been placed in 2021 and the products should be off the market,” McCullough said.
In McCullough’s view, “COVID-19 is not a seasonal illness, the vaccines are not safe for human use, annual shots are not medically necessary, clinically indicated, and not advised for any American.”
Brianne Dressen, co-chair of the nonprofit React19, which supports the COVID-19 vaccine-injured, said the group also disagrees with the FDA. She said:
“We are told to move on, but no one asks victims to forget an unacknowledged crime. When harm goes unanswered, the past doesn’t stay behind, it follows. Healing requires truth, accountability, and remembrance, not erasure.”
COVID vaccine package inserts also don’t disclose kids’ deaths
In the leaked memo, Prasad told the CBER team that a recent review of 96 deaths among U.S. children ages 7 to 16 concluded that “no fewer than 10” were related to the COVID-19 vaccine.
The actual number of child deaths caused by the COVID-19 vaccines is likely higher, as that number is “certainly an underestimate due to underreporting, and inherent bias in attribution,” Prasad wrote.
The deaths were reported to the Vaccine Adverse Event Reporting System (VAERS) between 2021 and 2024. Historically, VAERS has been shown to report only 1% of actual vaccine adverse events.
In May, the FDA directed Pfizer and Moderna to revise their COVID-19 vaccine label warnings by expanding the age group that may be at risk for vaccine-related myocarditis and pericarditis, and by warning that myocardial injury can be lasting among those who develop it.
However, the FDA has so far not required that the pediatric deaths be disclosed on the package inserts for the Moderna and Pfizer COVID-19 vaccines.
A black box warning would not have restricted people’s access to the vaccine, Demasi said. “It would simply have aligned the label with what the FDA already knows — ensuring that deaths were disclosed clearly, consistently, and without minimisation.”
U.S. Department of Health and Human Services (HHS) Spokesman Andrew Nixon declined to provide more details on the FDA’s rejection of a black box warning.
When The Defender pointed out that the FDA’s refusal to issue the warning appeared to contradict HHS’ commitment to transparency, Nixon said, “The FDA takes very seriously any death that is attributed to a regulated medical product.”
FDA plans to make COVID vaccine death reports public, Makary says
Freedom of Information Act requests by CHD and others have revealed that HHS officials under the Biden administration avoided issuing a formal warning to the American public and ignored 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 Centers for Disease Control and Prevention, FDA, U.S. Department of Defense, Pfizer and the Israeli Ministry of Health had documented evidence of myocarditis occurring 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, Makary acknowledged that under his predecessor, the agency sat on the data.
Related articles in The Defender- FDA May Slap COVID Vaccines With Black Box Warning, CNN Reports
- FDA Expands Probe Into COVID Vaccine-Related Deaths to Include Adults
- CHD Asks FDA to Revoke COVID Vaccine Licenses, Calls on Public to Submit ‘Hundreds of Thousands’ of Comments
- Leaked Memo: FDA Confirms ‘At Least’ 10 Child Deaths From COVID Vaccine, Promises Sweeping Reforms
- Pfizer, Moderna Must Add Stronger Warnings About Possible Heart Damage From COVID Vaccines, FDA Says
