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JAKARTA - The European Medicines Agency (EMA) has recommended the Novavax COVID-19 vaccine, warning against two types of heart inflammation, based on the small number of cases reported.

The conditions myocarditis and pericarditis should be listed as new side effects in the product information for the vaccine, Nuvaxovid, the EMA said on Wednesday.

Before Europe, the US Food and Drug Administration (FDA) flagged the risk of heart inflammation from the Novavax vaccine in early June.

Myocarditis and pericarditis were previously identified as rare side effects, mostly seen in young men, of the mRNA vaccine made by Moderna and the Pfizer-BioNTech alliance, with most of those affected making a full recovery.

The European Union agency said on Wednesday it asked US vaccine developer Novavax to provide additional data on the risk of side effects occurring. Novavax had no immediate comment.

Last month, the EMA identified a severe allergic reaction as a potential side effect of the vaccine.

Novavax is known to hope for people who choose not to use the Pfizer and Moderna vaccines, which are based on innovative messenger RNA (mRNA) technology. To later love their vaccine, because it relies on technology that has been used for decades to fight diseases including hepatitis B and the flu.

However, only about 250,000 doses of Nuvaxovid have been administered in Europe so far since its launch in December, according to the European Centers for Disease Prevention and Control.


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