EMA recommends Novavax list new side effects of Covid-19 vaccine. (Source: Reuters)

In a statement issued on August 3, the EMA said that Novavax should list the above-mentioned heart conditions as a new side effect in its Nuvaxovid vaccine product information section. The recommendation is based on several reported cases of myocarditis and pericarditis following vaccination with the Covid-19 vaccine developed by Novavax. The EMA said it had asked Novavax for more data on the risk of adverse effects.

For its part, Novavax's representative confirmed that there was no concern about myocarditis and pericarditis during clinical trials of the Nuvaxovid vaccine. The company representative also emphasized that the most common cause of myocarditis is viral infection and the company will collect more related data. “We will work with relevant authorities to ensure that our product information is consistent with the interpretation of the upcoming data,” Novavax stated.

In June, the US Food and Drug Administration (FDA) warned of the risk of myocarditis after receiving Novavax's Covid-19 vaccine. In July, the EMA identified serious allergic reactions as a potential side effect of the Nuvaxovid vaccine.

Previously, myocarditis and pericarditis were identified as rare side effects. As reported, cases mainly occurred in adolescents and young men after being vaccinated with the Covid-19 mRNA vaccine from Moderna and Pfizer/BioNTech. Most of these cases make a full recovery.

The Covid-19 vaccine produced by Novavax company has been licensed for use in dozens of countries around the world, including Korea, Indonesia, Australia, the European Union (EU), UK, Canada.... According to the European Center for Disease Control and Prevention, only 250,000 doses of the Novaxovid vaccine have been used in Europe so far since it was introduced in December last year.

Nuvaxovid vaccines are made using more conventional technology than vaccines prepared using mRNA technology. This vaccine consists of 2 basic injections for adults, each given 3 weeks apart. Nuvaxovid contains the spike protein of the SARS-CoV-2 virus and the adjuvant Matrix-M, which activates the immune response. This is a method of preparing vaccines to prevent other common diseases, including hepatitis. Nuvaxovid was shown to be 90% effective in preventing Covid-19 in trials conducted before the emergence of Delta and Omicron variants of the SARS-CoV-2 virus.