US FDA Concerned over Potential Novavax Myocarditis Risk

A vial labelled "Novavax COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. REUTERS/Dado Ruvic/Illustration
A vial labelled "Novavax COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. REUTERS/Dado Ruvic/Illustration
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US FDA Concerned over Potential Novavax Myocarditis Risk

A vial labelled "Novavax COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. REUTERS/Dado Ruvic/Illustration
A vial labelled "Novavax COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. REUTERS/Dado Ruvic/Illustration

The Food and Drug Administration voiced concern Friday about myocarditis being potentially linked to the Novavax Covid-19 vaccine, just as experts are to weigh its use in the United States.

The Novavax vaccine is already authorized in other countries, particularly in Europe. In the United States, an independent committee convened at the request of the FDA is to meet Tuesday to evaluate data from the clinical trials of Novavax and give its recommendation.

In advance of that, the agency published a lengthy document on Friday analyzing these results, as it had done for the three other vaccines already authorized in the country.

Shortly afterwards, Novavax stock dropped 20 percent on the New York Stock Exchange.

Novavax's vaccine was found to be 90 percent effective against symptomatic cases of the disease, in trials conducted before the appearance of the Omicron variant, according to the FDA.

But six cases of myocarditis, an inflammation of the heart muscle, were detected in the group that received the vaccine, against one case in the placebo group, the agency pointed out.

Five cases occurred within two weeks of vaccination.

"Identification of multiple potential vaccine-associated cases" out of 40,000 clinical trial participants "raises concern that if causally associated, the risk of myocarditis following" the Novavax shot "could be higher than reported" on other vaccines such as Pfizer or Moderna, the FDA said.

A small risk of myocarditis had in fact been identified after Pfizer or Moderna vaccinations, which are based on Messenger-RNA, particularly in young men and adolescent boys.

But the FDA noted that during clinical trials of these vaccines, no cases had yet been detected, and the agency appeared concerned that the risk is higher with Novavax.

The company issued a statement in response to the FDA report on Friday, saying "we believe there is insufficient evidence to establish a causal relationship", adding that it was normal "to see natural background events of myocarditis in any sufficiently large database."



Jeddah Season 2025 Launches Summer Entertainment Program

The program combines entertainment, culture, and tourism across several main destinations that include the city’s most iconic landmarks and key facilities - SPA
The program combines entertainment, culture, and tourism across several main destinations that include the city’s most iconic landmarks and key facilities - SPA
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Jeddah Season 2025 Launches Summer Entertainment Program

The program combines entertainment, culture, and tourism across several main destinations that include the city’s most iconic landmarks and key facilities - SPA
The program combines entertainment, culture, and tourism across several main destinations that include the city’s most iconic landmarks and key facilities - SPA

The integrated summer program of Jeddah Season 2025 officially launched under the theme “Jeddah is Different.”

The program combines entertainment, culture, and tourism across several main destinations that include the city’s most iconic landmarks and key facilities.

This launch aligns with the Kingdom’s efforts to realize the objectives of Saudi Vision 2030 by diversifying entertainment offerings and enhancing the quality of life for citizens, residents, and visitors alike, SPA reported.

At Jeddah Waterfront’s “Jeddah Promenade,” the opening night featured dazzling drone shows, roaming performances, and interactive entertainment characters, offering families and visitors a visually engaging experience. Meanwhile, the “Western Coast” event kicked off in the Obhur area, delivering a unique beach experience that runs until October 4.

The event offers a variety of safe, family-friendly activities including a ladies-only beach, water sports, and live artistic performances, creating a complete coastal entertainment experience catering to all age groups.

In parallel, the “Jeddah Shopping Festival,” which runs through August 31, is transforming the city into a vibrant commercial destination. It features hotel and transportation discounts, live shows, weekly giveaways, and promotional activities across major shopping centers.

Jeddah Season reflects a commitment to offering a comprehensive tourism experience that supports the goals of Vision 2030. It contributes to diversifying entertainment options, stimulating investment, enhancing Jeddah’s global standing as a premier tourism destination, and driving economic, cultural, and tourism growth.