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FDA considers possible myocarditis link in Novavax COVID-19 vaccine recipients

By Brian Buntz | June 6, 2022

NovavaxIn reviewing clinical trial data related to the Novavax (Nasdaq:NVAX) COVID-19 vaccine, FDA expressed concerns about the product’s potential to cause myocarditis, a type of heart inflammation.

In a briefing document, FDA noted that the “identification of multiple potential vaccine-associated cases in a premarket safety database of ~40,000 vaccine recipients raises concern.” The agency goes on to say that if causally associated, “the risk of myocarditis following NVX-CoV2373 could be higher than reported during post-authorization use of mRNA COVID-19 vaccines (for which no cases were identified in pre-authorization evaluation).”

In a statement, Novavax concluded that the rate of myocarditis and a similar condition known as pericarditis was similar across vaccine and placebo recipients. In the vaccine arm, 0.007% experienced such heart inflammation, while 0.005% of placebo recipients did.

Myocarditis is a risk occasionally associated with mRNA COVID-19 vaccines. A JAMA report noted that the risk of myocarditis was most common in adolescent males and young men.

A separate JAMA report estimated fewer than 30 cases of myocarditis per 100,000 mRNA vaccine recipients in Nordic countries.

NVAX shares dipped 14% on Friday but were up 7.55% to $48.14 in afternoon trading today.

The Novavax vaccine had an efficacy rate of 90.4% in the pivotal trial conducted in the U.S. and Mexico.

FDA plans on holding a VRBPAC meeting on June 7 to discuss granting emergency use authorization for the Novavax vaccine.


Filed Under: clinical trials, Drug Discovery, Infectious Disease
Tagged With: COVID-19 vaccine, COVID-19 vaccines, Myocarditis, Novavax
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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