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The EMA is asking for more data from US vaccine maker Novavax The FDA has previously highlighted the risk of heart inflammation Heart inflammation is a rare side effect of mRNA shots
LONDON, Aug 3 (Reuters) – The European Medicines Agency (EMA) is recommending that Novavax’s Covid-19 vaccine carry a warning about the possibility of two types of heart inflammation, an added burden for a vaccine that has so far failed to gain widespread acceptance. absorption. 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 announced on Wednesday. Novavax ( NVAX.O ) said no concerns about heart inflammation were raised during clinical trials of Nuvaxovid and that more data would be gathered, adding that the most common cause of myocarditis is viral infections. Sign up now for FREE unlimited access to Reuters.com Register “We will work with the relevant regulatory authorities to ensure that our product information is consistent with our shared interpretation of the incoming data,” US vaccine developer Novavax added. In June, the US Food and Drug Administration highlighted the risk of heart inflammation from the Novavax vaccine. read more Myocarditis and pericarditis were previously identified as rare side effects, mostly in young men, of the pioneering messenger RNA (mRNA) vaccines made by Moderna ( MRNA.O ) and the Pfizer and BioNTech ( 22UAy.DE ) alliance, with the the vast majority of those affected make a full recovery. The EMA said on Wednesday that it has asked Novavax to provide additional data on the risk of these side effects. Last month, the EU agency identified severe allergic reactions as possible side effects of the vaccine. read more Novavax hoped that people who chose not to get Pfizer’s and Moderna’s vaccines would favor its vaccine because it is based on technology that has been used for decades to fight diseases such as hepatitis B and the flu. However, only 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. Sign up now for FREE unlimited access to Reuters.com Register Reporting by Natalie Grover in London and Ludwig Burger in Frankfurt, additional reporting by Michael Erman in New York. edited by Jason Neely, Emelia Sithole-Matarise and Alexander Smith Our Standards: The Thomson Reuters Trust Principles.
