European regulatory agency says Novavax Covid-19 vaccine must carry heart-side effect warning

The following is an excerpt from Reuters.

The European Medicines Agency (EMA) is recommending Novavax's Covid-19 vaccine carry a warning of the possibility of two types of heart inflammation, an added burden for a shot that has so far failed to win wide uptake.

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The heart conditions - myocarditis and pericarditis - should be listed as new side effects in the product information for the vaccine, Nuvaxovid, based on a small number of reported cases, the EMA said on Wednesday.

Novavax (NVAX.O) said no concerns about heart inflammations were raised during the clinical trials of Nuvaxovid and that more data would be gathered, adding that the most common cause of myocarditis is viral infections.

The EMA said on Wednesday it had asked Novavax to provide additional data on the risk of these side effects.

Last month, the EU agency identified severe allergic reactions as potential side effects of the vaccine. 

In June, the U.S. Food and Drug Administration flagged a risk of heart inflammation from the Novavax vaccine.

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