FDA intends to put its most serious warning on Covid vaccines, sources say

CNN-The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

A boxed warning, which appears at the top of prescribing information for medicines, is the agency’s most serious, designed to warn about risks such as death or life-threatening or disabling reactions that should be weighed against the intervention’s benefits. They can also be used when a risk might be lowered by using a medicine in a targeted way, such as only in certain groups.

Boxed warnings on opioids, for example, warn about risks of abuse, addiction, overdose and death. The acne medication Accutane carried a warning about the risks of birth defects when used during pregnancy. ACAM2000, a smallpox and mpox vaccine, has a warning about complications such as heart inflammation and encephalitis.

The plan to install the warnings for Covid-19 vaccines is being orchestrated by Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, according to one person, who declined to be named because they weren’t authorized to share the information publicly.

The plan has not been finalized and may still change. It wasn’t immediately clear whether the plans for the warnings, expected to be unveiled by the end of the year, would be applied only to mRNA vaccines or to all Covid-19 vaccines, or whether they would apply to all age groups. Three vaccines are approved by the FDA for use in the US, and two of them — from Pfizer and Moderna – use mRNA technology, which has been a key focus of the administration.

“Unless the FDA announces it, any claim about what it will do is pure speculation,” US Department of Health and Human Services spokesperson Andrew Nixon said Thursday.

In response to CNN’s inquiry about the FDA’s plans, Moderna pointed to a statement it issued in September about the safety of its Covid-19 vaccine, SpikeVax. It notes that the safety of its vaccine is “rigorously monitored by Moderna, the US FDA, and regulators in more than 90 countries,” and that, with more than a billion doses distributed worldwide, those systems “have not reported any new or undisclosed safety concerns in children or pregnant women.”

Pfizer too issued a statement in September supporting the safety and efficacy of its Covid-19 vaccine. The statements from both companies came after reports that federal health officials might seek to tie the vaccines to safety risks in pregnant women and children. Pfizer declined to provide further comment Thursday.

One study estimated that in their first year of use, Covid-19 vaccinations averted almost 20 million deaths around the world.

Children who received Covid-19 vaccines in the 2024-25 respiratory virus season also had a “substantially lower risk” of emergency department and urgent care visits related to the virus, according to a CDC report published Thursday. The vaccines were about 76% effective in preventing these outcomes among healthy children ages 9 months to 4 years and about 56% effective among children ages 5 to 17 compared with those who did not receive an updated vaccine for the 2024-25 season.

The record-speed development of Covid-19 vaccines during the pandemic, under the project dubbed Operation Warp Speed, was a crowning achievement of President Donald Trump’s first term, one that several Republican lawmakers have recently said should be awarded the Nobel Peace Prize. But Trump installed as his Health and Human Services Secretary Robert F. Kennedy Jr., a vaccine skeptic who has faced criticism from public health experts and lawmakers for his efforts to impose his personal views despite the science.

Kennedy and his allies have long questioned the safety and effectiveness of the Covid-19 vaccines, which were studied in placebo-controlled trials in about 75,000 people and given to millions of people in the US and around the world during the pandemic.

Prasad has been a controversial figure, both in his role at the FDA and previously, as a podcaster and professor in the Department of Epidemiology and Biostatistics at the University of California at San Francisco. A critic of the government’s response to the Covid-19 pandemic and vaccine policy, he was named CBER director under FDA Commissioner Dr. Marty Makary in May before resigning in July under pressure from the White House and right-wing activist Laura Loomer. Prasad then returned to the job weeks later.

In late November, Prasad sent a memo to staff within CBER, the division at the FDA that oversees vaccines, claiming that staff in the agency’s Office of Biostatistics and Pharmacovigilance had “found that at least 10 children have died after and because of receiving Covid-19 vaccination.” He did not provide additional information but promised “swift action” in response.

“The FDA takes very seriously any death that is attributed to a regulated medical product,” Nixon, of HHS, said Thursday.

In May, the FDA said it was requiring safety warnings in the prescribing information for the Covid-19 vaccines from Pfizer and Moderna. Issam Ahmed/AFP/Getty Images

Prasad focused on myocarditis, or heart inflammation, a very rare side effect after administration of the mRNA vaccines. It was detected with early use of those shots, when the first and second doses were recommended to be spaced as closely as three weeks apart, and was predominantly seen in boys and young men.

A presentation from the US Centers for Disease Control and Prevention in June said most adolescents and young adults recovered from myocarditis after vaccination, and it found no known deaths or heart transplants. Rates have declined significantly in more recent years as the recommended interval between the first and second doses in the initial series has been lengthened for the mRNA vaccines.

Still, the FDA said in May that it was requiring safety warnings in the prescribing information for Pfizer and Moderna’s Covid-19 vaccines about the risk of myocarditis and pericarditis, or inflammation of the tissue surrounding the heart, to be expanded to a broader age range. The labels now say, “the observed risk has been highest in males 12 years through 24 years of age.”

On Tuesday, Children’s Health Defense, the nonprofit led by Kennedy before his presidential bid, filed a citizen petition saying the agency should revoke the licenses for the vaccines. It argues that the mRNA vaccines are misbranded because they were initially approved under the standards of emergency use authorizations.

HHS also said this week that the FDA was looking into whether deaths “across multiple age groups” might be related to Covid-19 vaccines.

Prasad’s memo, which promised an overhaul of how the FDA regulates vaccines more broadly, drew alarm from outside public health experts, many of whom demanded to see the data supporting Prasad’s claims. A dozen former FDA commissioners wrote an open letter published in the New England Journal of Medicine expressing concern around “sweeping new FDA assertions about vaccine safety.”

“What’s happening now is death by a thousand cuts,” said one person familiar with how the agency works, who declined to be named because they were not authorized to share the information with a reporter.

Recent messaging by the administration that goes against established scientific evidence – saying, for example, that vaccines are riskier when given together and that kids get too many vaccines that have potentially dangerous ingredients – is working to weaken the public’s confidence in lifesaving shots, the person said.

“What we’re watching is misinformation and lies in aggregate that will discourage the population from vaccination. It will lead us to, ultimately, to having loss of life unnecessarily, and it’s very disturbing,” the person added.

Dr. Aaron Kesselheim, who runs the Program on Regulation, Therapeutics and Law at Harvard University, said these kinds of warnings can be initiated by the manufacturer or the FDA, but typically, the agency notifies the public that it’s looking into a safety question around a drug or vaccine. It may also convene an advisory committee — a panel of independent outside experts – to publicly vet the safety data and give advice.

None of these steps seems to have been taken so far. The FDA’s media office didn’t respond to a question about whether the agency planned to hold an advisory committee meeting on the issue.

“I guess my concern is that in this case, there’s not a process,” said Kesselheim, who has studied the impact of black box warnings on drug labels. “There isn’t that same opportunity for discussion and good-faith review of the data on which this decision is being made.

“My concern is that this will be seen as yet another in the long line of decisions that this FDA is making based on its own political goals, rather than after a dutiful and thoughtful and public review of the science.”

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