The U.S. Food and Drug Administration (FDA) on Friday expressed concern about a risk of myocarditis that may be linked to Novavax’s COVID-19 vaccine ahead of an expert meeting scheduled to decide on the drug’s approval in the United States next week.
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The Novavax vaccine is already approved in other countries, particularly in Europe.
In the USA, an independent committee convened at the request of the FDA is to meet on Tuesday to evaluate the data from the clinical studies on Novavax and to make a recommendation. Upstream, the agency released a lengthy document on Friday analyzing those results, as it had done for the three other vaccines already approved in the country.
Novavax’s stock has plummeted 20% on the New York Stock Exchange as a result.
Novavax’s vaccine was shown to be 90% effective against symptomatic cases of the disease in studies conducted prior to the release of the Omicron variant, according to the FDA.
However, six cases of myocarditis, an inflammation of the heart muscle, were detected in the group that received the vaccine, versus one case in the placebo group, the agency pointed out. Five cases occurred within two weeks of vaccination.
“The identification of multiple potentially vaccine-related cases” from 40,000 clinical trial participants “raises concern that the risk of myocarditis after vaccination with NVX-CoV2373 may be higher than reported during the period if a causal relationship exists Period after approval of messenger RNA vaccines,” the FDA explained in its analysis.
The risk of myocarditis has indeed been identified after vaccination with Pfizer or Moderna, particularly in young men and adolescents. However, the FDA recalled that no cases had yet been detected during clinical trials of these vaccines. She seems concerned that this risk is higher with Novavax.
The company issued a response statement on Friday: “We believe there is insufficient evidence to establish a causal link” between the myocarditis cases and the vaccine, she said, adding it was normal to “expect that.” a series of myocarditis occurs”. the population anyway ‘in any sufficiently large database’.