FDA expanding COVID vaccine warnings over rare heart side effect
The Food and Drug Administration is now requiring two common COVID-19 vaccines to update their warning labels to include information on two rare heart side effects.
Myocarditis — inflammation of the heart muscle — and pericarditis — inflammation of the thin sac surrounding the heart — are two conditions that a small number of people have experienced after receiving the mRNA COVID-19 shot.
The rare cases of myocarditis have mainly impacted adolescent and young adult men about a week after getting the shot, according to the Centers for Disease Control and Prevention (CDC).
Most of the reported cases of the condition have been mild.
Moderna and Pfizer COVID-19 vaccines have included information on their warning labels about the conditions since 2021. The updated warnings will now feature information on how the conditions have been seen most commonly among boys aged 12 and older and young men as old as 24.
The updated labels will also state that the risk of developing myocarditis or pericarditis is about eight per one million doses in babies at least 6 months old to adults as old as 64. For males, the number jumps to about 27 cases per million doses for those ages 12-24.
Earlier warning labels on the shots said that the risks were highest among adolescent men between ages 12-17, according to the The Associated Press. The data on the updated labels also appears to conflict with previous findings by CDC scientists who concluded that the shots did not pose an increased risk of either myocarditis or pericarditis, the outlet added.
The FDA released the updated labels shortly after the Health and Human Services Secretary Robert F. Kennedy Jr's newly remade federal vaccine advisory panel met to review whether the COVID-19 vaccine should continue to be recommended to healthy children and pregnant women.
Kennedy dismissed all 17 previous members of the Advisory Committee on Immunization Practices (ACIP) earlier this month, accusing them of conflicts of interest. He replaced them two days later with an 8-person group that includes several anti-vaccine voices.
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