The COVID-19 vaccine made by U.S.-based Novavax can lead to the same types of heart inflammation that have occurred after vaccination with the Pfizer and Moderna shots, Europe's drug regulator said on Aug. 3.
The European Medicines Agency said the vaccine, known as Nuvaxovid, should have myocarditis and pericarditis listed as side effects in the product information for the vaccine.
Prospective recipients and healthcare professionals should be warned about the issue, the organization said.
It has asked Novavax to provide additional data on the side effects.
Anaphylaxis, or severe allergic reaction, is already listed in Europe as a side effect of Nuvaxovid, which European regulators cleared in December 2021.
Novavax told The Epoch Times in an email that in clinical trials of its vaccine, the rate of myocarditis was close between those receiving the vaccine and those receiving the placebo.
"As more data becomes available, we will better understand the nature and magnitude of any potential risk of myocarditis and pericarditis. We will work with the relevant regulators to assure our product information is consistent with our common interpretation of the incoming data," the vaccine maker said.
Just 250,091 doses have been administered in Europe in about eight months, according to the European Center for Disease Prevention and Control.
Risk FlaggedNations outside Europe, including Japan and the United States, have flagged heart inflammation as a risk following Novavax vaccination.
U.S. regulators said the Novavax trials did raise concerns about the conditions.
The trial data "provide evidence for increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart)," the U.S. Food and Drug Administration said.
Recipients and healthcare providers were alerted to the risk through fact sheets.
Myocarditis and pericarditis have occurred at higher-than-background rates in people receiving the Moderna and Pfizer vaccines, particularly young males.
Some countries have paused or curtailed administration of vaccinations because of the side effects since young people are already at much lower risk from COVID-19 than the elderly and infirm.
Novavax was ordered by the administration to conduct post-authorization observational studies to evaluate the link between Novavax's vaccine and a list of adverse events of special interest, including myocarditis and pericarditis.