All Myocarditis, Pericarditis Cases With COVID-19 Vaccines Now Must Be Reported To VAERS

The change to three vaccine emergency use authorizations was made quietly, most recently for the Novavax vaccine.

myocarditis and COVID-19 vaccine
Myocarditis and pericarditis reporting are not conditions of three of the four COVID-19 vaccine emergency use authorizations. • Source: Shutterstock

Myocarditis and pericarditis remain enough of a concern with the COVID-19 vaccines that the US Food and Drug Administration is demanding sponsors report all incidences, no matter their severity.

The FDA updated the emergency use authorizations for three vaccines to specifically state that both conditions must be reported to the Vaccine Adverse Event Reporting System (VAERS)

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