Washington (AP) The Food and Drug Administration said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rareheart side effectmainly 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. Physicians are already advised about the problem via prescribing information from Moderna and Pfizer.
The FDA wrote to both pharmaceutical companies in April, requesting that they revise and broaden the warnings to include more information about the issue and to include a wider range of patients. Although the FDA has the authority to require label modifications, the procedure is frequently more of a discussion with businesses.
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. Additionally, the label states that males between the ages of 12 and 24 have been the most affected. According to the former designation, the issue primarily affects children aged 12 to 17.
The FDA’s labeling modification seems to go against certain earlier conclusions made by scientists in other parts of the US 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. This is the first meeting of the CDC advisory panel since Kennedy abruptly fired all 17 of the group’s members and appointed a new panel with a number of people who had previously made anti-vaccine remarks.
The most recent move by Kennedy administration officials to limit or undermine vaccination usage is the FDA’s label modification. 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.
The latest warning is the wrong strategy, according to outside experts.
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. In order to forecast and reduce the danger of myocarditis, we should be looking into who is susceptible to it.
During the pandemic, Makary and a number of other FDA officials rose to notoriety by claiming that the federal government minimized critical side effects like myocarditis and overstated the advantages of COVID-19 boosters.
Makary and two of his current FDA deputies wrote a 2022 paper prior to joining the administration arguing that requiring booster doses for youth would result in greater vaccine-related harm than avoidable hospitalizations from COVID-19 infections. Many prominent public health and vaccine specialists at the time, including those at the CDC, disagreed with the result.
The Robert Wood Johnson Foundation and the Science and Educational Media Group of the Howard Hughes Medical Institute provide support to the Associated Press Health and Science Department. All content is entirely the AP’s responsibility.
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