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FDA says Novavax vaccine may cause heart inflammation risk


Shares of Novavax Inc.'s high-profile COVID-19 vaccine tumbled after the U.S. Food and Drug Administration (FDA) warned it could cause heart inflammation. Reuters, Investing.com, CNN and other foreign sources reported on the 3rd that the FDA released a briefing on the 3rd that Novavax’s clinical trials conducted on nearly 30,000 subjects from December 2020 to September 2021 showed that its protein-based The COVID-19 vaccine was effective in reducing the risk of moderate to severe disease, with an efficacy rate of up to 90.4% within two and a half months after two doses. However, the documents show that 6 cases developed symptoms of myocarditis or pericarditis after being vaccinated with the Novavax vaccine "NVX-CoV2373", of which 5 were male and aged between 16 and 67. Five of the six cases were hospitalized and all have now recovered. The FDA believes that these events suggest a causal link between myocarditis/pericarditis and vaccination, similar to the mRNA COVID-19 vaccine, requiring Novavax to display a warning. Novavax has yet to agree, though. Novavax responded to the FDA that as long as the sample size is large enough, cases of myocarditis will naturally occur, and young men are at higher risk. Myocarditis is mostly caused by infection with an unspecified virus. According to the company's interpretation of the clinical trial data, there is insufficient evidence to prove a causal relationship between the two.
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