Associated Press, by Matthew Perrone
Washington (AP)The Food and Drug Administration announced on Wednesday that it has increased the number of warnings on a rare heart side effect that primarily affects young males that are now present on the two primary COVID-19 vaccines.
After the first shots were made publicly available in 2021, myocarditis—a minor kind of heart inflammation—became a consequence. 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.
The risk of myocarditis, according to the revised warning, is 8 cases per 1 million for those who received the 2023–2024 COVID vaccine between the ages of 6 months and 64. 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.
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The Centers for Disease Control and Prevention earlier determined that government vaccine injury databases for COVID-19 injections going back to 2022 did not show any elevated risk of myocarditis. Additionally, officials pointed out that cases linked to the COVID-19 infection itself, which can also result in myocarditis, are typically less severe and resolve more quickly.
The FDA’s disclosure coincided with a meeting of newly constituted vaccine experts appointed by Health Secretary Robert F. Kennedy Jr. to discuss the continued use of COVID-19 vaccinations for important populations, such as children and 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.Seniors and other Americans who are more susceptible to the virus were recently denied yearly COVID-19 vaccinations by FDA Commissioner Marty Makary and a top deputy. In order to keep up with the most recent strains of viruses, they have also proposed seasonal adjustments for new items that need more testing.
The latest warning is the wrong strategy, according to outside experts.
Dr. Robert Morris of the University of Washington stated that while they are correct to point out that we should take into account the risks of myocarditis that come with the vaccine, their suggested remedy is completely incorrect. 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 recent FDA appointees rose to notoriety by claiming the federal government minimized major side effects, such as 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.
