The U.S. Food and Drug Administration (FDA) staff said on Friday (3rd) that although Novavax provided data showing that its vaccine can effectively reduce the risk of mild to severe infection following infection with the new crown, the vaccine is still suspected of causing myocarditis. Shares of Novavax fell more than 20% on the news.
In Novavax’s 30,000-patient trial between December 2020 and September 2021, there were four cases of myocarditis, with symptoms appearing approximately 20 days following vaccination.
The cases raised concerns regarding a causal link between the vaccine and myocarditis, FDA staff wrote in a briefing document released Friday. In addition, the FDA also asked Novavax to list myocarditis and another type of pericarditis (Pericarditis) as “important identified risks” of the vaccine data, but Novavax did not agree to be included, indicating that its clinical trials of myocarditis cases The numbers are “within the expected range of background cases”.
Shares of Novavax tumbled on news of the FDA’s analysis, and by press time, Novavax (NVAX-US) shares plummeted 23.99% during the session, and the share price was tentatively reported at $42.54.
However, the FDA’s analysis of Novavax vaccine data before Omicron and Delta became mainstream variant strains showed that Novavax’s new crown vaccine can protect once morest infection caused by Omicron virus, especially reducing the chance of severe illness. “
