The European Medicines Agency (EMA) today recommended adding a warning for two types of heart inflammation to Novavax’s COVID-19 vaccine, marketed under the brand names Nuvaxovid and Covovax, based on a small number of cases reported in those who received the vaccine.
According to a statement, the EMA’s Pharmacovigilance Risk Assessment Committee — responsible for assessing and monitoring the safety of human medicines — concluded that “myocarditis and pericarditis can occur following vaccination with Nuvaxovid.”
“The Committee is therefore recommending listing myocarditis and pericarditis as new side effects in the product information for Nuvaxovid, together with a warning to raise awareness among healthcare professionals and people receiving this vaccine,” the statement said….