US FDA Raises Concerns Over Myocarditis Link to Novavax COVID-19 Vaccine

After Clinical Trials with 40,000 Participants, 6 Cases Reported
"Risk Higher Than Pfizer and Moderna"
FDA Requires Myocarditis Warning for Novavax Vaccine
Novavax Denies, Citing Insufficient Evidence of Causality

On February 14, the first day of Novavax vaccine administration for unvaccinated individuals aged 18 and over or high-risk groups, healthcare workers at the vaccination room of Buk-gu Public Health Center in Gwangju are checking the quantity of Novavax vaccines to support medical institutions in case of vaccine supply instability.
[Photo by Yonhap News]

[Asia Economy Intern Reporter Kim Nayeon] The U.S. Food and Drug Administration (FDA) has raised concerns that the COVID-19 vaccine developed by the American pharmaceutical company Novavax may be associated with cases of myocarditis.

According to AFP and other news agencies on the 3rd (local time), the FDA revealed the following in a report analyzing the clinical trial results of the Novavax vaccine, which involved over 40,000 participants.

According to the report, the Novavax vaccine showed about 90% effectiveness in preventing symptomatic COVID-19 infections in clinical trials conducted before the emergence of the Omicron variant.

However, six cases of myocarditis, an inflammation of the heart muscle, were found in the group that received the Novavax vaccine, with five cases occurring within two weeks after vaccination. There was one case in the placebo group.

The FDA pointed out, "The discovery of such cases possibly related to the vaccine among 40,000 clinical trial participants suggests that if there is a causal relationship, the subsequent risk of myocarditis may be higher than that reported with other vaccines."

In the United States, COVID-19 vaccines developed by Pfizer-BioNTech and Moderna have been approved and distributed by authorities. These messenger RNA (mRNA) vaccines have also shown a small number of myocarditis cases, mostly in young men and adolescent males.

The FDA stated that no myocarditis cases have been found so far in the clinical trials of Pfizer and Moderna vaccines, leading to the inference that the myocarditis risk associated with Novavax may be higher than those vaccines.

The FDA has requested Novavax to label the risks of myocarditis and pericarditis as "important identified risks."

However, Novavax responded by stating, "After analyzing all clinical data, we determined that there is insufficient evidence to establish a causal relationship," and argued, "Observing the natural occurrence of myocarditis in sufficiently large data sets is entirely normal," rejecting the FDA's request.

Meanwhile, following the release of the report, Novavax's stock price plunged 20% on the New York Stock Exchange.

This content was produced with the assistance of AI translation services.