Moderna Says It Doesn’t See Signs That Shot Causes Heart Issue
(Bloomberg) -- Moderna Inc. said that scientific evidence it has reviewed doesn’t suggest that its Covid-19 vaccine was the cause of a heart condition in some people who received it.
The drugmaker said in a statement Friday that after reviewing the available safety data on its shot for cases of myocarditis and pericarditis, it “has not established a causal association with its vaccine.”
U.S. public health advisers plan to meet later this month to discuss a potential link between Covid-19 shots that use messenger RNA technology, which include Moderna’s vaccine and one made by Pfizer Inc. and BioNTech SE, and heart inflammation after hundreds of vaccinated people experienced myocarditis.
Moderna said it “will continue to closely monitor these reports and is actively working with public health and regulatory authorities to further assess this issue.”
The Centers for Disease Control and Prevention has identified a total of 216 cases of heart inflammation after the first dose of an mRNA shot, and another 573 cases after the second dose. The median age of people with myocarditis or pericarditis following the first dose was 30, and 24 in the second-dose cases. There were 475 cases among people under 30.
Moderna’s vaccine is now authorized for adults 18 and up, but it is under FDA review for children ages 12 to 17.
Most patients have responded well to treatment and rest, according to the CDC, and more than 8 in 10 have had full relief from their symptoms. The agency is further examining the cases by age.
About 130 million Americans have received the full two-dose regimen of one of the two authorized mRNA vaccines.
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