The European Medicines Agency 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 Reuters, the U.S. Food and Drug Administration (FDA) flagged a risk of heart inflammation from the Novavax vaccine in early June.
However, the agency on July 13 granted Novavax’s request for Emergency Use Authorization of the vaccine for adults 18 and over in the U.S.
… The FDA asked Novavax to “flag” myocarditis and pericarditis as an “important identified risk” in its materials accompanying the vaccine. However, Novavax has not yet agreed to do so.
… Novavax claimed that “natural background events” of myocarditis can be expected in any large database and the “totality of the clinical evidence” is “not enough to establish an overall causal relationship with the vaccine.”