COVID-19 vaccines are unlikely to cause a rare inflammatory disease linked to coronavirus infection in children, according to an analysis of US government data released Tuesday.
The disease, formally known as multisystem inflammatory syndrome in children, causes fever and symptoms that affect at least two organs and often include stomach pain, a rash or red eyes. It is an unusual complication in children who have contracted COVID-19, and it very rarely affects adults. The condition usually leads to hospitalization, but most patients recover.
First reported in the UK in early 2020, it is often confused with Kawasaki disease, which can cause inflammation and heart problems. Since February 2020, more than 6,800 cases have been reported in the United States, according to the Centers for Disease Control and Prevention (CDC).
As part of monitoring the safety of the COVID-19 vaccine, the CDC and the Food and Drug Administration (FDA) included the condition on a list of possible complications of special concern. A few reported cases in people with no detectable evidence of coronavirus infection prompted researchers at the CDC and elsewhere to conduct the new analysis, which was published Tuesday in The Lancet Child & Adolescent Health.
The possibility that vaccines could somehow cause the disease is only theoretical, and the review found no evidence for it, said study co-author Dr. Buddy Creech, a specialist in pediatric infectious diseases at Vanderbilt University, who directs a study on the effect on children of vaccines against COVID-19 developed by Moderna.
“We don’t know what the exact contribution of the vaccine to these diseases is,” Creech said. “Vaccine alone, in the absence of a preceding infection, does not appear to be a substantial trigger,” he added.
The analysis included data from the first nine months of COVID-19 vaccination in the United States, from December 2020 to August 2021. During that time, the FDA authorized the use of the Pfizer-developed COVID-19 vaccine for youth. 16 years and older; expanded it in May to cover those ages 12 to 15, and licensed Moderna and Johnson & Johnson vaccines for those 18 and older.
The results show that inflammatory disease could occur after vaccination in one in a million children who have contracted COVID-19, and in one in 3 million who have no detectable evidence of a previous coronavirus infection.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education.
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