COVID-19 vaccines are unlikely to cause a rare inflammatory condition in children

COVID-19 vaccines are unlikely to cause a rare inflammatory condition linked to coronavirus infection in children, according to an analysis of US government data published Tuesday.

The condition, formally known as childhood multisystem inflammatory syndrome, involves fever plus symptoms affecting at least two organs and often includes stomach pain, skin rash, or bloodshot eyes. It is a rare complication in children who have had COVID-19 and is rare in adults. The condition often leads to hospitalization, but most patients recover.

First reported in the UK in early 2020, it is sometimes mistaken for Kawasaki disease, which can cause swelling and heart problems. More than 6,800 cases have been reported in the US as of February 2020, according to the Centers for Disease Control and Prevention.
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As part of its surveillance of the safety of the COVID-19 vaccine, the CDC and the U.S. Food and Drug Administration have added the condition to a list of several potential adverse events of particular concern. A few cases reported in people with no demonstrable evidence of coronavirus infection prompted researchers at the CDC and elsewhere to conduct the new analysis, published Tuesday in the Lancet Child & Adolescent Health.

The possibility that the vaccines could somehow cause the condition is only theoretical, and the analysis found no evidence that this was the case, said study co-author Dr. Buddy Creech, a pediatric infectious disease specialist at Vanderbilt University who is leading a study on Moderna injections in children.

“We don’t know the exact contribution of the vaccine to these diseases,” Creech said. “Vaccine alone in the absence of prior infection does not appear to be a substantial trigger.”

Read more: Why you should vaccinate your children against COVID-19

The analysis included surveillance data for the first nine months of COVID-19 vaccination in the US, from December 2020 through August 2021. During that time, the FDA cleared Pfizer’s COVID-19 injections for ages 16 and older. ; expanded that to 12 to 15 years in May; and authorized recordings of Moderna and Johnson & Johnson for ages 18 and older.

More than 21 million people ages 12 to 20 received at least one vaccine dose during that time. Twenty-one of them developed the inflammatory condition afterward. They had all received Pfizer injections, the analysis found. Fifteen of the 21 had lab records of a previous COVID-19 infection that could have caused the condition.

The remaining six had no evidence of a previous infection, but the researchers said they could not definitively conclude that they had never had COVID-19 or any other infection that could have led to the inflammatory condition. Children with COVID-19 often have no symptoms and many are never tested.

The results suggest that the inflammatory condition can occur after vaccination in 1 in 1 million children who have had COVID-19, and in 1 in 3 million who have no demonstrable evidence of a previous COVID-19 infection.

Most children who had COVID-19 do not develop the disease after infection, but it is estimated to happen at a significantly higher rate than either rate after vaccination. From April to June 2020, the rate was 200 cases per million in unvaccinated infected people aged 12-20 years in the US

“Their findings are generally quite reassuring,” Dr. Mary Beth Son of Boston Children’s Hospital wrote in a commentary accompanying the study.

dr. Adam Ratner, a pediatric scientist at New York University Langone Health, said the results show the chances are “super rare” that the injections trigger an immune response that could lead to the inflammatory condition. In contrast, there is strong evidence that vaccination protects children from getting COVID-19 and the condition, Ratner said.

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