LONDON (Reuters) – The European Medicines Agency (EMA) is recommending Novavax’s COVID-19 vaccine carry a warning of two inflammatory conditions of the heart, based on a small number of reported cases.
The conditions – myocarditis and pericarditis – should be listed as new side effects in the product information for the vaccine, Nuvaxovid, the EMA said on Wednesday.
The agency has also requested that the U.S. drugmaker provide additional data on the risk of these side effects occurring.
(Reporting by Natalie Grover in London; editing by Jason Neely)
