Based on a small number of reported cases, Novavax’s COVID-19 vaccine must carry a warning of two inflammatory conditions of the heart, the European Medicines Agency (EMA) recommended on Wednesday.
It also cautioned of side effects such as tingling or decreased feeling in the skin.
The agency identified last month severe allergic reactions, i.e. anaphylaxis, as potential side effects of the Novavax COVID vaccine, sold as Nuvaxovid in Europe since December, and later agreed with the Maryland-based drugmaker to update the vaccine label accordingly.
The EMA added an additional burden for the vaccine that has so far failed to win wide uptake, pointing out that the product information for the two-dose Nuvaxovid should list myocarditis and pericarditis as new side effects.
Meanwhile, the EU agency requested additional data on the risk of these side effects occurring from the US drugmaker and vaccine developer that has so far issued no comment.
Back in early June, the US Food and Drug Administration (FDA) also flagged a risk of heart inflammation from Nuvaxovid while Australia recently added pericarditis, or inflammation of the heart lining, as a side effect of Nuvaxovid at the beginning of the year.
Both inflammatory conditions of the heart were previously identified as rare side effects that occurred mostly in young men that have received the Covid-19 mRNA vaccines made by Moderna or Pfizer/ BioNTech.
Since its jab relies on decades-old technology that has been used to combat diseases including hepatitis B and influenza, Novavax was hoping to attract people that were avoiding the jabs made with the groundbreaking mRNA technology.
Yet, it seems that those hopes were in vain since the European Centre for Disease Prevention and Control’s data shows that only around 250,000 doses of Nuvaxovid have been administered in Europe since December.