Novavax COVID-19 vaccine may cause heart inflammation: European regulator


A COVID-19 vaccine manufactured by U.S.-based Novavax could cause the same type of heart inflammation that occurred after vaccination with shots from Pfizer and Moderna, European drug regulators said Aug. 3. said on the day

The European Medicines Agency said the vaccine, known as Nuvaxovid, should list myocarditis and pericarditis as side effects in the vaccine’s product information.

Prospective recipients and medical professionals should be warned about the problem, the organization said.

We asked Novavax to provide additional data on side effects.

Anaphylaxis, or a severe allergic reaction, is already listed in Europe as a side effect of Nuvaxovid cleared by European regulators in December 2021.

Novavax told news outlets it found no signs of heart inflammation in clinical trials of its jab.

“We will work with relevant regulatory authorities to ensure that product information is consistent with the prevailing interpretation of incoming data,” the vaccine manufacturer said.

According to the European Center for Disease Prevention and Control, 250,091 doses were given in Europe in about eight months.

US regulators only recently approved and recommended the injection, and it remains unclear how many people in the country have been vaccinated since vaccination began on August 1. .

risk flagged

Cardiac inflammation has been reported as a risk after Novavax vaccination in non-European countries, including Japan and the United States.

US regulators said the Novavax trial raised concerns about the conditions.

The U.S. Food and Drug Administration said the trial data “provides evidence of an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart).”

Recipients and providers were warned of the risks in fact sheets.

Myocarditis and pericarditis occur at higher than background rates in people who receive Moderna and Pfizer vaccines, especially young men.

Some countries have suspended or reduced vaccination doses due to side effects, as young people are already at much lower risk of COVID-19 than the elderly and infirm.

Novavax has been mandated by the government to conduct a post-approval observational study to assess the association between the Novavax vaccine and a list of adverse events of special interest, including myocarditis and pericarditis. I was.

Zachary Stever

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Zachary Stieber covers US and world news. He is based in Maryland.

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