LONDON, Aug 4 (BUS) – The European Medicines Agency (EMA) has recommended that Novavax’s COVID-19 vaccine carry a warning of possible two types of carditis, an additional burden for the episode that has so far failed to win widely. Exploit.
Heart conditions — myocarditis and pericarditis — should be listed as new side effects in product information for the vaccine, Nuvaxovid, based on a small number of reported cases, according to the EMA.
Novavax said there were no concerns about heart infections during clinical trials of Novaxovid and that more data would be collected, adding that the most common cause of myocarditis was viral infections, Reuters reported.
US vaccine developer Novavax added: “We will work with relevant regulators to ensure that our product information is consistent with our joint interpretation of the data received.”
The U.S. Food and Drug Administration has indicated a risk of heart infection from the Novavax vaccine.
Myocarditis and pericarditis have previously been identified as rare side effects, mostly observed in young adults, from pioneering RNA (mRNA) vaccines made by the Moderna, Pfizer and BioNTech alliance, with the vast majority of those infected making a full recovery.
The Environmental Protection Agency said it has asked Novavax to provide additional data about the risks of these side effects.
Last month, the European Union agency identified severe allergic reactions as a possible side effect of the vaccine.
Novavax was hoping that people who chose not to take the Pfizer and Moderna vaccines would prefer the shot because it relies on technology used for decades to fight diseases including hepatitis B and influenza.
About 250,000 doses of Nuvaxovid have been administered in Europe since its launch in December, according to the European Center for Disease Prevention and Control.
ZHB