LONDON: The European Medicines Agency (EMA) recommends that Novavax COVID-19 vaccine warn of the potential for two types of heart inflammation, an added burden for a shot that has so far failed to gain wide lead.
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 Wednesday.
Novavax said no concerns about heart inflammation were raised during clinical trials of Nuvaxovid. More data will be collected, stating that a viral infection is the most common cause of myocarditis.
“We will work with relevant regulators to ensure that our product information is consistent with our general interpretation of incoming data,” said US vaccine developer Novavax.
In June, the U.S. Food and Drug Administration flagged a risk of heart inflammation from the Novavax vaccine.
Myocarditis and pericarditis were previously identified as rare side effects, mostly seen in young men, from groundbreaking messenger RNA (mRNA) vaccines made by Moderna and the Pfizer and BioNTech alliance, with the vast majority of those affected recovering fully.
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
Novavax was hoping that people who have opted not to take Pfizer and Moderna’s vaccines would favour its shot because it relies on technology that has been used for decades to combat diseases, including hepatitis B and influenza.
However, only around 250,000 doses of Nuvaxovid have been administered in Europe since its launch in December, according to the European Centre for Disease Prevention and Control.