US FDA to add heart inflammation warning to Pfizer, Moderna COVID-19 vaccines

The US Food and Drug Administration (USFDA) will add a warning about rare heart inflammation cases among adolescents and young adults to its fact sheets for the Pfizer-BioNTech and Moderna COVID-19 vaccines.

"Based on the available data, a warning statement in the factsheets for both healthcare providers and vaccine recipients and caregivers would be warranted," FDA official Doran Fink said. The CDC has also told doctors and hospitals to look out for symptoms like myocarditis and pericarditis.

This comes after the US Centers for Disease Control and Prevention (US CDC) advisory groups found that inflammation in young adults was allegedly linked to vaccines but the benefits clearly outweighed the risk, Reuters reported. The health regulator noted that those who report heart inflammation after inoculation generally recover from the symptoms.

The US Department of Health and Human Services also said the heart side effect is "extremely rare" and underscored the safety and efficacy of COVID-19 vaccines. "We strongly encourage everyone age 12 and older who are eligible to receive the vaccine under Emergency Use Authorisation to get vaccinated," the US Department of Health and Human Services said in a statement.

Cases of heart inflammation are higher in the week following the second dose of the COVID-19 vaccine and in males, as per the data available with the CDC. It added that these cases are found more in people in their teens and those in their early 20s. The Health regulator identified 309 hospitalisations, of which 295 have been discharged.

Edited by Mehak Agarwal; with agency inputs

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