By Ben Tinker, Brenda Goodman, Meg Tirrell, CNN<\/p>\n\n\n\n
The US Food and Drug Administration intends to put a \u201cblack box\u201d warning on Covid-19 vaccines, according to two people familiar with the agency\u2019s plans, the latest move by President Donald Trump\u2019s health officials to undermine a vaccine that was a standout victory of his first term. The plan shocked outside experts, who said there was no basis for the warning.<\/p>\n\n\n\n
A boxed warning, which appears at the top of prescribing information for medicines, is the agency\u2019s most serious, designed<\/a> to warn about risks such as death or life-threatening or disabling reactions that should be weighed against the intervention\u2019s 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.<\/p>\n\n\n\n Boxed warnings on opioids, for example, warn about risks of abuse, addiction, overdose and death. The acne medication Accutane carried a warning<\/a> about the risks of birth defects when used during pregnancy. ACAM2000, a smallpox and mpox vaccine, has a warning<\/a> about complications such as heart inflammation and encephalitis.<\/p>\n\n\n\n The plan to install the warnings for Covid-19 vaccines is being orchestrated by Dr. Vinay Prasad, the FDA\u2019s chief medical and scientific officer and director of the agency\u2019s Center for Biologics Evaluation and Research, according to one person, who declined to be named because they weren\u2019t authorized to share the information publicly.<\/p>\n\n\n\n The plan has not been finalized and may still change. It wasn\u2019t 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 \u2014 from Pfizer and Moderna \u2013 use mRNA technology, which has been a key focus of the administration.<\/p>\n\n\n\n \u201cUnless the FDA announces it, any claim about what it will do is pure speculation,\u201d US Department of Health and Human Services spokesperson Andrew Nixon said Thursday.<\/p>\n\n\n\n In response to CNN\u2019s inquiry about the FDA\u2019s plans, Moderna pointed to a statement<\/a> it issued in September about the safety of its Covid-19 vaccine, SpikeVax. It notes that the safety of its vaccine is \u201crigorously monitored by Moderna, the US FDA, and regulators in more than 90 countries,\u201d and that, with more than a billion doses distributed worldwide, those systems \u201chave not reported any new or undisclosed safety concerns in children or pregnant women.\u201d<\/p>\n\n\n\n Pfizer too issued a statement<\/a> in September supporting the safety and efficacy of its Covid-19 vaccine. The statements from both companies came after reports<\/a> 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.<\/p>\n\n\n\n One study<\/a> estimated that in their first year of use, Covid-19 vaccinations averted almost 20 million deaths around the world.<\/p>\n\n\n\n Children who received Covid-19 vaccines in the 2024-25 respiratory virus season also had a \u201csubstantially lower risk\u201d of emergency department and urgent care visits related to the virus, according to a CDC report<\/a> 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.<\/p>\n\n\n\n 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\u2019s first term, one that several Republican lawmakers have recently said<\/a> 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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\u2019s response to the Covid-19 pandemic and vaccine policy, he was named<\/a> 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<\/a> to the job weeks later.<\/p>\n\n\n\n In late November, Prasad sent a memo<\/a> to staff within CBER, the division at the FDA that oversees vaccines, claiming that staff in the agency\u2019s Office of Biostatistics and Pharmacovigilance had \u201cfound that at least 10 children have died after and because of receiving Covid-19 vaccination.\u201d He did not provide additional information but promised \u201cswift action\u201d in response.<\/p>\n\n\n\n \u201cThe FDA takes very seriously any death that is attributed to a regulated medical product,\u201d Nixon, of HHS, said Thursday.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n A presentation<\/a> 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.<\/p>\n\n\n\n Still, the FDA said in May that it was requiring<\/a> safety warnings in the prescribing information for Pfizer<\/a> and Moderna\u2019s<\/a> 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, \u201cthe observed risk has been highest in males 12 years through 24 years of age.\u201d<\/p>\n\n\n\n On Tuesday, Children\u2019s 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<\/a> are misbranded because they were initially approved under the standards of emergency use authorizations.<\/p>\n\n\n\nAdministration targets vaccines<\/h3>\n\n\n\n