The FDA is drawing up plans to put a “black box” warning on COVID vaccines, the agency’s most serious warning over potential side effects. A black box warning, which appears at the top of prescribing information, is placed on drugs or vaccines to highlight major risks such as serious side effects or restrictions. The warnings are intended to bring the attention of consumers and physicians to a serious side effect. They may be used if there is evidence of a severe, life-threatening or permanently disabling risk from a medication. The potential decision comes after a Stanford University study published yesterday revealed how COVID mRNA shots can cause myocarditis, an extremely rare complication of the vaccine that causes inflammation of the heart muscle. Data shows about one in 125,000 children and adults under 65 who were vaccinated against the virus between 2023 and 2024 developed the condition within seven days of their inoculation. About 270 million people in the US, or 81% of the population, have received at least one dose of the mRNA COVID vaccine to date. The government says it has received 10,000 claims that someone suffered an injury or death after taking a COVID vaccine.
