Washington (AP)-United States Health Authorities reported on Wednesday that they have expanded existing warnings with respect to the two main vaccines against COVID-19 with respect to a rare cardiac side effect that has been seen mainly in young men.
Myocarditis, a type of inflammation of the heart that is usually mild, emerged as a complication after the first vaccines were widely available in 2021. Pfizer and modern information that accompanies vaccines already warns doctors about this problem.
In April, the Food and Medicines Administration (FDA) sent cards to both medicine manufacturers, asking them to update and expand warnings to add more details about the problem and cover a wider group of patients. Although the FDA can demand changes in the labels, often the process is more a negotiation with companies.
Specifically, the new warning indicates that the risk of myocarditis is 8 cases for every million people who received vaccines against COVID-19 from 2023 to 2024 between the ages of 6 months and 64 years. The label also notes that the problem has been more common among men aged 12 to 24. The previous label said that the problem occurred mainly in young people aged 12 to 17.
The change in the FDA labeling seems to conflict with some previous findings of scientists in other parts of the United States government.
The Centers for Disease Control and Prevention (CDC) previously concluded that there was no increase in the risk of myocarditis in government databases of vaccine injuries for vaccines against COVID-19 since 2022. The officials also indicated that the cases tend to be resolved quickly and are less serious than those linked to those linked to those linked to the infection of COVID. It can cause myocarditis.
The FDA made its announcement at a time when new vaccine advisors appointed by the Secretary of Health, Robert F. Kennedy Jr., gathered to discuss the use of vaccines against COVID-19 for key population groups, including pregnant women. It is the first meeting of the CDC advisory panel since Kennedy dismissed abruptly to the 17 members of the group, appointing a new panel that includes several members with a history of having made anti -vacacun statements.
The label update ordered by the FDA is the most recent measure taken by officials working under Kennedy’s supervision to restrict or undermine the use of vaccines.
The FDA Commissioner Marty Makary, and a high subordinate of his recently restricted access to annual vaccines against COVID-19 to older adults and other Americans who run greater risk if they contract the virus. They have also stated that seasonal adjustments so that vaccines coincide with the most recent virus strains in circulation are new products that require additional tests. External experts said the new warning is the wrong approach. “They are right to suggest that we need to take into account the risks of myocarditis linked to 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 forecast and mitigate that risk.” Makary and several other FDA officials were the subject of attention during the pandemic by stating that the federal government exaggerated the benefits of reinforcements against COVID-19 and minimized the serious side effects, including myocarditis. Before joining the government, Makary and two of its current subordinates of the FDA wrote an article in 2022 that said that demanding that young people apply reinforcements would cause more injuries related to the vaccine than the number of hospitalizations that could be avoided by Covid-19 infections. The conclusion contradicted that of many leaders in vaccines and public health at that time, including those of the CDC. ___ The Department of Health and Science of The Associated Press receives support from the group of educational and scientific media of the Howard Hughes Medical Institute and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. ___ This story was translated from English by an AP editor with the help of a generative artificial intelligence tool.
