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The Food and Drug Administration (FDA) has directed COVID-19 vaccine manufacturers to expand the warning for two forms of inflammation, according to letters made public on May 21.
The FDA told BioNTech, which produces a vaccine with Pfizer, and Moderna to update warnings regarding myocarditis—or heart inflammation—and the related condition pericarditis.Richard Forshee, acting director of the FDA’s Office of Biostatistics and Pharmacovigilance, said that new information has emerged, including a 2024 FDA study that found that some myocarditis patients had signs of heart scarring months after vaccination.
The companies must update labels to state that following administration of the 2023–2024 versions of the vaccines, “the highest estimated incidence of myocarditis and/or pericarditis was in males 16 through 25 years of age,” Forshee said. The highest estimated incidence of the post-vaccination inflammation is about 38 cases per million doses for both vaccines, according to the proposed update.
Current warnings on the highest observed risk in Young Males
The current warnings say that the highest observed risk after Moderna vaccination is in males aged 18 to 24 and that the highest risk after Pfizer-BioNTech vaccination is in males aged 12 to 17.
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The companies were also directed to add new information summarizing the FDA study, including that “at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common.” The updates should also state that “it is not known if these heart MRI findings might predict long-term heart effects of myocarditis,” according to the letters.
The FDA first added warnings to the labels for the vaccines in June 2021, several months after officials learned of post-vaccination myocarditis cases.
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The letters are dated April 17. It’s not clear why they were not released until May 21. The FDA did not respond to a request for comment by publication time.
“Americans deserve radical transparency around the safety and efficacy of COVID vaccines and the FDA is delivering on their promise to do just that,” a spokesperson for the Department of Health and Human Services (HHS), the FDA’s parent agency, told The Epoch Times in an email.
Individuals aware of COVID vaccine-related adverse events resulting in myocarditis and pericarditis
The department stated that Pfizer and Moderna should take steps to ensure that individuals are aware of COVID vaccine-related adverse events resulting in myocarditis and pericarditis in their Spikevax and Comirnaty vaccines.
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The Centers for Disease Control and Prevention (CDC), another HHS component, said in May that although an increased risk of myocarditis following COVID-19 vaccination was observed from 2020 to 2022, no such risk was detected in two of the primary safety systems, the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink, for the 2023–2024 or 2024–2025 formulations. The CDC says on its website that evidence from the systems and elsewhere “supports a causal association” with the BioNTech-Pfizer and Moderna vaccines.
HHS: “CDC the systems on Vaccine Safety are deficient”.
The HHS
said in April that the systems are deficient and that the agency is building better ones.
Under the Federal Food, Drug, and Cosmetic Act, the FDA has the authority to order updates to labels if the agency becomes aware of new safety information. Sources can include new analyses of existing information and information that has emerged since the last assessment of the products.
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After a company receives a labeling notice from the FDA, it has 30 days to either submit a reply that agrees that an update is needed and outlines proposed labeling changes to reflect the new information or tell the FDA it does not think that a labeling change is warranted.
It’s not known whether any of the companies have challenged the directives.
BioNTech, Pfizer, and Moderna did not return inquiries by publication time.
by Zachary Stieber – originally piublished on The Epoch Times
Zachary Stieber is a senior reporter for The Epoch Times based in Maryland. He covers U.S. and world news. Contact Zachary at zack.stieber@epochtimes.com
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