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European Medicines Agency Adds Heart Inflammation Warning Requirement to COVID-19 Vaccine

Novavax has been authorized both in Europe and the United States


The European Union agency that oversees the evolution, supervision and monitoring of medicine has recommended a health warning be added to Novavax’s COVID-19 vaccine.

The European Medicines Agency is recommending the shots include a caution to patients about an increased risk of two types of heart inflammation – myocarditis and pericarditis. The announcement comes one month after the agency found severe allergic reaction is a potential side effect of the vaccine.

Known commercially as Nuvaxovid, the product became the fifth vaccine the EMA recommended for authorization on Dec. 20 after declaring the protein-based vaccine safe for people over the age of 18.

“After a thorough evaluation, EMA’s human medicines committee … concluded by consensus that the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality,” the agency stated.

At the time, the agency reported mild to moderate side effects such as tiredness, muscle pain, headache, a general feeling of being unwell, joint pain, and nausea or vomiting which could occur a few days after the initial injection.

Roughly 250,000 doses of Nuvaxoid have since been distributed across Europe according to data from the European Centre for Disease Prevention and Control.

Myocarditis and pericarditis are considered rare side effects. In a study with 40,000 participants, the forms of heart inflammation were detected six times.

The Novavax vaccine is a protein adjuvant that strengthens the immune system response.

While other vaccines trick the body’s cells into creating parts of the virus that can trigger the immune system, the Novavax vaccine takes a different approach,” says Yale Medicine. “It contains the spike protein of the coronavirus itself, but formulated as a nanoparticle, which cannot cause disease. When the vaccine is injected, this stimulates the immune system to produce antibodies and T-cell immune responses.”

Because its vaccine relies on traditionally used technology rather than mRNA, Novavax believed its product would be favorable among people who had chosen not to get Pfizer and Moderna’s COVID-19 vaccine, per The Straits Times

A United States Food and Drug Administration advisory committee recommended the Nuvaxovid vaccine for emergency use authorization for individuals over the age of 18 on June 7.

“The advisory committee’s positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology,” said Stanley C. Erck, the President and Chief Executive Officer of Maryland-based Novavax, in a press release.

Briefing documents released in June indicated the agency found a “causal association” between the vaccine and heart inflammation that was “similar to the association documented with mRNA COVID-19 vaccines.”

The product was subsequently authorized by the FDA in July.

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