FDA requires updated warning about rare heart risk with COVID shots
WASHINGTON (AP) — The Food and Drug Administration said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rare heart side effect mainly seen in young men.
Myocarditis, a type of heart inflammation that is usually mild, emerged as a complication after the first shots became widely available in 2021. Prescribing information from both Pfizer and Moderna already advises doctors about the issue.
In April, the FDA sent letters to both drugmakers asking them to update and expand the warnings to add more detail about the problem and to cover a larger group of patients. While the FDA can mandate label changes, the process is often more of a negotiation with companies.
Specifically, the new warning lists the risk of myocarditis as 8 cases per 1 million people who got the 2023-2024 COVID shots between the ages of 6 months and 64 years old. The label also notes that the problem has been most common among males ages 12 to 24. The previous label said the problem mostly occurs in 12- to 17-year-olds.
The FDA's labeling change appears to conflict with some prior findings of scientists elsewhere in the U.S. government.
The Centers for Disease Control and Prevention previously concluded there was no increased risk of myocarditis detected in government vaccine injury databases for COVID-19 shots dating back to 2022. Officials also noted that cases tend to resolve quickly and are less severe than those associated with COVID-19 infection itself, which can also cause myocarditis.
The FDA announcement came as new vaccine advisers appointed by Health Secretary Robert F. Kennedy Jr. met to debate the continuing use of COVID-19 vaccines for key groups, including pregnant women. It's the first meeting of the CDC advisory panel since Kennedy abruptly dismissed all 17 members of the group, naming a new panel that includes several members with a history of anti-vaccine statements.
The FDA's label update is the latest step by officials working under Kennedy to restrict or undercut use of vaccines. FDA Commissioner Marty Makary and a top deputy recently restricted annual COVID-19 shots to seniors and other Americans at higher risk from the virus. They've also suggested seasonal tweaks to match the latest circulating virus strains are new products that require extra testing.
Outside experts said the new warning is the wrong approach.
'They are right to suggest that we need to consider myocarditis risks associated with the vaccine, but what they propose is exactly the wrong solution,' said Dr. Robert Morris, a public health specialist at the University of Washington. 'We should be investigating who is prone to myocarditis to see if we can predict and mitigate that risk.'
Makary and several other FDA officials gained prominence during the pandemic by suggesting the federal government exaggerated the benefits of COVID-19 boosters and downplayed serious side effects, including myocarditis.
Before joining the government, Makary and two of his current FDA deputies wrote a 2022 paper that said mandating booster shots in young people would cause more vaccine-related injuries than prevented hospitalizations from COVID-19 infections. The conclusion contradicted that of many leading vaccine and public health experts at the time, including at the CDC.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
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CNN
2 hours ago
- CNN
What to know about thimerosal, a target of RFK Jr.'s new CDC vaccine advisers
A century ago, one of the biggest safety concerns about vaccines involved bacterial contamination. In 1916, four young children died in South Carolina after receiving typhoid vaccine that had been contaminated with Staphylococcus aureus bacteria. Twelve years later, 12 children in Queensland, Australia, died from tainted immunizations against diphtheria. In the 1930s, vaccine makers began using a preservative called thimerosal to stave off microbial growth in their products. For the next six decades, it didn't receive much notice; ill effects appeared limited to minor local injection-site reactions, according to the US Food and Drug Administration. That changed in 1999, when US health officials asked pharmaceutical companies to remove thimerosal from vaccines. There was no evidence that it caused harm in the quantities used, but thimerosal contains a form of mercury, and questions had emerged about whether it could cause neurotoxicity when given in childhood vaccinations. Vaccine makers have removed it from all but a few shots, such as multidose vials of flu vaccine. In the meantime, subsequent studies have confirmed no link between thimerosal in vaccines and neurodevelopmental issues, including autism, and autism rates have continued to rise. So public health experts were puzzled when the preservative appeared on the agenda for this week's meeting of outside vaccine advisers to the US Centers for Disease Control and Prevention. 'I actually don't know any pediatric practices that even use that multidose influenza vaccine,' said Dr. Sean O'Leary, a pediatrician at Children's Hospital Colorado and former liaison to the CDC's Advisory Committee on Immunization Practices, or ACIP, for the American Academy of Pediatrics. The group is meeting on Wednesday and Thursday for the first time since US Health and Human Services Secretary Robert F. Kennedy Jr. dismissed the committee's previous 17 members, claiming they had conflicts of interest, and days later installed eight new advisers. Public health experts and lawmakers have called into question the credentials and backgrounds of some of the new panelists, and just before the meeting began, one member withdrew during the financial holdings review, an HHS spokesman said, bringing the panel down to seven. A presentation 'regarding thimerosal in vaccines' is scheduled for Thursday morning, followed by 'proposed recommendations' specifically about thimerosal in flu vaccines, according to an agenda posted Monday. The meeting is scheduled to conclude with a vote on the latter, a move that could lead to official CDC policy if adopted by agency leadership – or, without a confirmed director in place, by Kennedy. The last-minute addition of thimerosal to the agenda was a red flag for vaccine experts, who consider the science settled and fear that Kennedy – who led an anti-vaccine group called Children's Health Defense – is seeking to sow doubt about vaccine safety. Another former Children's Health Defense leader, Lyn Redwood, is slated to make a presentation on the topic at the meeting. Here's how thimerosal became such a hot-button issue. In 1997, Rep. Frank Pallone, a New Jersey Democrat concerned about mercury pollution in his community's lakes and rivers, attached an amendment to a US Food and Drug Administration reauthorization bill that would require the agency to catalogue intentionally introduced mercury compounds in drugs and food. That led to a possibly startling discovery: 'As people looked in vaccines, there was the potential that, by six months of age, infants could have received more thimerosal than was listed in several sources of what was considered safe levels of mercury,' said Dr. Walter Orenstein, who was director of the National Immunization Program at the CDC at the time. But those limits were set for methylmercury, the kind found in some fish, which is known to be toxic. Thimerosal contains ethylmercury, a different compound that's 'intrinsically less stable, and more readily metabolized, than methylmercury,' said Dr. Matthew Rand, an associate professor in the Department of Environmental Medicine at the University of Rochester who studies mercury toxicity. That means it's cleared from the body more quickly than methylmercury, according to the CDC, 'and is therefore less likely to cause any harm.' The FDA notes that there were no existing guidelines for ethylmercury. 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Vaccines had already been tied to autism in 1998 by British doctor Andrew Wakefield, who published a since-retracted paper that claimed the measles-mumps-rubella vaccine was linked to autism, although not because of thimerosal – the MMR vaccine never contained the preservative. Still, parents of children with autism were seeking answers. One of those parents was Redwood, who said that in 1999, she tallied up her son's mercury exposure and found 'at two months of age, he had received 125 times his allowable exposure to mercury based on EPA's guidelines in his weight.' 'That was a real answer for me,' Redwood said in a video posted by Children's Health Defense this month, 'because my son at this time was almost 5 years old, and he had regressed developmentally after his first year of life and was diagnosed with autism.' Redwood, a nurse practioner, decided to become an advocate, speaking at events and publishing papers about thimerosal and autism. The uproar over a potential link between thimerosal and autism came as a surprise to Orenstein and colleagues. 'Mercury itself had never been implicated as a major cause of autism,' Orenstein said. 'But this was a major, major concern.' It led to a number of studies of the issue, including a 2004 assessment by the Institute of Medicine (now known as the National Academy of Medicine) that concluded 'the body of epidemiological evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism.' It made the same conclusion for MMR vaccines and autism. A 2010 study by the CDC also found no link. And 'even after thimerosal was removed from almost all childhood vaccines, autism rates continued to increase,' the agency noted, 'which is the opposite of what would be expected if thimerosal caused autism.' Still, those who continued to push the disproven autism connection included Kennedy, who published a book in 2014 called 'Thimerosal: Let the Science Speak.' Its subtitle calls for the 'immediate removal of mercury – a known neurotoxin – from vaccines.' It rejects the findings of the 2004 Institute of Medicine report and warns that millions of children in the US and around the world 'appear to be at risk of injury from the thimerosal in vaccines.' Thimerosal is still present in 'a small percentage of flu vaccines, confined to multidose vials,' according to a post from the Vaccine Integrity Project, a group focused on countering vaccine misinformation that was started at the University of Minnesota's Center for Infectious Disease Research and Policy, or CIDRAP. The group suspects that thimerosal is included on ACIP's agenda this week – with a presentation by Redwood and a vote by the committee – 'to put greater focus on and generate more public discussion about vaccine risk.' HHS didn't return a request for comment about Redwood's involvement in this week's meeting, and Redwood declined to comment. Her presentation slides, however, were posted ahead of the meeting and continued to claim thimerosal presents safety risks. One slide initially included in the presentation cited a study in animals that appeared not to exist; its apparent lead author told CNN he'd published a study with a similar title, but in a different journal, in different animals, and with dramatically different findings — ones that didn't appear to show a link between autism and thimerosal. The slide presentation was subsequently updated to remove that slide. CDC staff also posted its own review of the data, citing nearly two dozen studies showing 'the evidence does not support an association between thimerosal-containing vaccines and autism spectrum disorder or other neurodevelopmental disorders.' 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USA Today
4 hours ago
- USA Today
Inside the unusual, RFK-appointed panel that's deciding on childhood vaccines
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