FDA Weighs Black Box Warning for COVID Vaccines

31 March 2024
by: Juicing For Health
in Lifestyle & Wellness

Last updated on

A quiet shift may be underway at one of America’s most powerful health agencies. According to sources familiar with internal discussions, officials at the U.S. Food and Drug Administration are weighing whether to add a black box warning to COVID-19 vaccines. Such a move would represent the strongest regulatory caution the agency can issue, reserved for drugs and medical products carrying risks of death or serious injury. Reports of these plans have sent ripples through the public health community, drawing sharp criticism from former regulators and outside experts who question whether science backed research or politics is driving the decision. With an announcement potentially coming before the year’s end, questions about vaccine safety have once again moved to center stage in American public discourse.

What a Black Box Warning Signals

For those unfamiliar with pharmaceutical regulation, a boxed warning carries significant weight. It appears at the very top of prescribing information and serves as a red flag for doctors and patients alike. Opioid painkillers carry such warnings due to addiction and overdose risks. Accutane, an acne medication, earned one because of birth defect risks during pregnancy. Adding COVID vaccines to that list would place them alongside some of the most carefully scrutinized medical products on the market. It would also mark a dramatic turn for shots that health officials credited with ending the deadliest phase of the pandemic. HHS spokesperson Andrew Nixon urged caution about reading too much into unconfirmed reports. “Unless the FDA announces it, any claim about what it will do is pure speculation,” Nixon said when asked about the agency’s intentions.

Behind Closed Doors at the FDA

Dr. Vinay Prasad, who serves as the FDA’s chief medical and scientific officer and heads the Center for Biologics Evaluation and Research, is reportedly orchestrating the effort to add warnings. Prasad has been a controversial figure both inside and outside government. Before joining the FDA, he built a following as a podcaster and professor at the University of California at San Francisco, where he frequently criticized pandemic response policies. His tenure at the agency has been turbulent. Prasad resigned in July under pressure from the White House and right-wing activist Laura Loomer, only to return weeks later. In late November, he sent a memo to staff claiming that at least 10 children had died after receiving the COVID-19 vaccination due to heart inflammation. He promised swift action but provided few details to support the claim. Plans remain fluid, and officials have not confirmed whether any warning would apply to all COVID vaccines or only those using mRNA technology. Three vaccines currently hold FDA approval for use in America. Pfizer and Moderna both produce mRNA shots, while Novavax offers a more traditional protein-based vaccine. Whether warnings would cover all age groups also remains uncertain.

Heart Inflammation Risks Already on Labels

Human heart disease symbol illustration
Concerns about myocarditis and pericarditis, two forms of heart inflammation, are not new. The FDA added warnings about these risks to mRNA vaccine labels back in 2021 after reports emerged of cases occurring shortly after vaccination. Young males appeared most vulnerable, particularly when early dosing schedules called for shots just three weeks apart. In May 2025, the FDA required Pfizer and Moderna to expand these warnings across a broader age range. Updated labels now state that the observed risk has been highest in males aged 12 through 24. A June 2025 safety communication provided more specific numbers drawn from insurance claims data. Roughly 8 cases of heart inflammation occurred per million doses among people aged 6 months through 64 years. Among males 12 through 24, that figure rose to approximately 27 cases per million doses. A follow-up study funded partly by the FDA tracked about 300 people who developed myocarditis after vaccination. Cardiac MRI scans taken roughly five months after diagnosis commonly showed signs of heart muscle injury. Some patients improved over time, but not all. Researchers acknowledged they do not yet know whether these findings predict long-term heart problems. CDC data from June indicated most adolescents and young adults recovered from vaccine-associated myocarditis, with no known deaths or heart transplants among those cases. Rates have declined in recent years as recommended intervals between doses lengthened.

A French Study Offers Reassurance

While American regulators consider adding warnings, a major study from France published in December 2025 found no increased long-term mortality risk among vaccinated adults. Researchers followed 22.7 million vaccinated individuals and 5.9 million unvaccinated people over a median period of 45 months. All participants were between 18 and 59 years old. Vaccinated individuals showed a 25 percent lower risk of dying from any cause compared to their unvaccinated counterparts. Risk of dying in hospital from severe COVID dropped by 74 percent among those who received shots. Results remained consistent across age groups, sexes, and among people with chronic health conditions. Researchers used sophisticated statistical methods to account for differences between vaccinated and unvaccinated groups. Even after adjusting for factors that might skew results, vaccination continued to show protective effects against mortality. The authors concluded their findings support the long-term safety of mRNA vaccines.

Vaccines Credited With Saving Millions of Lives

Beyond individual studies, broader estimates have credited COVID vaccines with preventing catastrophic loss of life worldwide. One analysis estimated that during their first year of use, vaccinations averted nearly 20 million deaths globally. By December 2023, roughly 67 percent of the world’s population had received at least one COVID vaccine dose, according to World Health Organization figures. Protection is extended to children as well. A CDC report examining the 2024-25 respiratory virus season found vaccinated children had a substantially lower risk of COVID-related emergency department and urgent care visits. Vaccines proved about 76 percent effective at preventing these outcomes among healthy children aged 9 months to 4 years and about 56 percent effective among those aged 5 to 17. Around 7.1 million people worldwide have died from COVID since the pandemic began, underscoring both the disease’s deadly toll and the stakes involved in vaccination policy.

Experts Question Whether Science Is Guiding Decisions

Public health experts have expressed alarm not just at the prospect of new warnings but at how the decision appears to be unfolding. Normally, the FDA notifies the public when investigating safety questions and may convene advisory committees of independent experts to review data publicly. Dr. Aaron Kesselheim, who runs the Program on Regulation, Therapeutics and Law at Harvard University and has studied black box warnings extensively, told CNN he sees troubling departures from standard practice. “I guess my concern is that in this case, there’s not a process,” Kesselheim said. “There isn’t that same opportunity for discussion and good-faith review of the data on which this decision is being made.” A dozen former FDA commissioners signed an open letter published in the New England Journal of Medicine expressing concern about what they called sweeping new assertions about vaccine safety. Dr. Angela Rasmussen, a virologist at the University of Saskatchewan who co-edits the journal Vaccine, said the scientific basis for a black box warning remains unclear. She noted that Prasad and other administration officials have long histories of opposing COVID vaccines and suggested the move appears designed to justify predetermined conclusions rather than follow evidence. One former federal health official, speaking anonymously, described current policy as “death by a thousand cuts,” warning that accumulated messaging against vaccines would discourage people from getting shots and ultimately cost lives.

Political Currents Running Through Health Policy

Vaccine skepticism has found a powerful champion in Health Secretary Robert F. Kennedy Jr., who has long questioned vaccine safety despite scientific consensus supporting their benefits. Before joining the administration, Kennedy led Children’s Health Defense, a nonprofit that has spread misinformation about vaccines. That organization filed a citizen petition in December asking the FDA to revoke licenses for mRNA vaccines entirely. Kennedy has already moved to limit COVID vaccine access, restricting shots to people 65 and older or those with underlying health conditions. Critics argue these restrictions ignore evidence showing vaccines benefit younger populations as well. Dr. Fiona Havers, a medical epidemiologist who resigned from the CDC in June over what she described as administration interference in vaccine programs, pointed to what she sees as dangerously one-sided messaging. “But to only talk about potential harms for vaccines, without talking about the thousands of hospitalizations and the many pediatric deaths that these vaccines prevented, is irresponsible and not how our government should be messaging about vaccines to the public,” Havers said.

Vaccine Makers Stand Behind Their Products

Both Pfizer and Moderna have pushed back against suggestions their vaccines pose unacknowledged dangers. In statements issued earlier in 2025, both companies pointed to extensive safety monitoring by regulators in dozens of countries. Moderna noted that after distributing more than one billion doses worldwide, safety monitoring systems have not reported any new or undisclosed concerns in children or pregnant women. Pfizer emphasized that its vaccine continues to demonstrate a favorable safety and efficacy profile supported by real-world evidence.

All Eyes on FDA as Year-End Deadline Looms

FDA has not set a firm timeline, though sources indicate any announcement could come before the year’s end. Nixon, the HHS spokesperson, maintained that all safety questions undergo review through established scientific and regulatory processes, with decisions based on rigorous evaluation of data. For millions of Americans who received COVID vaccines, news of potential black box warnings raises understandable concerns. Yet context matters. Rare adverse events can occur with any vaccine or medication. Balancing those risks against the benefits of protection from a disease that killed millions requires careful, transparent analysis. Whether the FDA’s process meets that standard remains an open question, one that public health experts and ordinary citizens alike will be watching closely in the weeks ahead.

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