FDA requires updated warning about rare heart risk with COVID shots
Washington – Washington (AP) – Food and Drug Administration said on Wednesday that it had expanded existing warnings to the two main COVID -19 vaccines on a rare heart effect mainly observed in young men.
Myocarditis, a type of cardiac inflammation which is generally light, emerged as a complication after the first shots became widely available in 2021. Pfizer and Moderna information prescription already advises doctors on the issue.
In April, the FDA sent letters to the two drug manufacturers asking them to update and expand the warnings to add more details on the problem and to cover a larger group of patients. Although the FDA can mandate label changes, the process is often more negotiation with companies.
More specifically, the new warning lists the risk of myocarditis as 8 cases for 1 million people who obtained the boost 2023-2024 between 6 months and 64 years. The label also notes that the problem was most common in men aged 12 to 24. The previous label said that the problem occurs mainly in the 12 to 17 year olds.
The change of labeling of the FDA seems to be conflict with certain previous conclusions of scientists elsewhere in the American government.
Centers for Disease Control and Prevention previously concluded that there was no increased risk of myocarditis detected in government databases on the lesions of the Vaccine for COVVI-19 plans dating from 2022. Managers also noted that cases tend to resolve quickly and are less serious than those associated with COVVI-19 infection itself, which can also cause myocarditis.
The FDA’s announcement came while new vaccination advisers appointed by the health secretary, Robert F. Kennedy Jr., met to debate the continuous use of COVVI-19 vaccines for key groups, including pregnant women. This is the first meeting of the CDC advisory committee since Kennedy suddenly rejected the 17 members of the group, appointing a new panel which includes several members with anti-vaccine statements.
Updating the FDA label is the last step by managers working under Kennedy to restrict or underestimate the use of vaccines. The FDA commissioner, Marty Makary, and a high-level deputy recently limited COVID-19 shots to the elderly and other Americans at the highest risk of the virus. They also suggested seasonal adjustments to match the latest circulating virus strains are new products that require additional tests.
External experts said the new warning is the wrong approach.
“They are right to suggest that we have to consider the risks of myocarditis associated with the vaccine, but what they offer is exactly the wrong solution,” said Dr. Robert Morris, specialist in public health at Washington University. “We should study who is subject to myocarditis to see if we can predict and alleviate this risk.”
Makary and several other FDA officials have taken importance during the pandemic by suggesting that the federal government has exaggerated the advantages of COVVI-19 boosters and minimized serious side effects, including myocarditis.
Before joining the government, Makary and two of his current FDA deputies wrote a document in 2022 which indicated that the compulsory booster strokes would cause more injuries related to vaccination than hospitalizations prevented COVVI-19 infections. The conclusion contradicted that of many main experts in vaccine and public health at the time, including the CDC.
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