EU Says Novavax COVID Shot Must Carry Heart Side-Effect Warning
Key Excerpts from Article on Website of U.S. News & World Report/Reuters
Posted: August 8th, 2022
The European Medicines Agency (EMA) is recommending Novavax's COVID-19 vaccine carry a warning of the possibility of two types of heart inflammation. 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. Novavax said no concerns about heart inflammations were raised during the clinical trials of Nuvaxovid and that more data would be gathered. "We will work with the relevant regulators to assure our product information is consistent with our common interpretation of the incoming data," U.S. vaccine developer Novavax added. 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. 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. However, only around 250,000 doses of Nuvaxovid have been administered in Europe.