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The U.S. Food and Drug Administration (FDA) released an assessment on Friday regarding the causal relationship between the Novavax vaccine and heart inflammation or myocarditis.
The assessment was released days before an FDA advisory panel on whether to authorize the vaccine for use in adults 18 and above.
In the FDA documents , the agency said that multiple events of myocarditis/pericarditis were reported after the administration of the Novavax vaccine. Thus, raising concern about a possible risk of heart inflammation from the vaccine.
“Multiple events of myocarditis/ pericarditis were reported in temporal relationship to NVX-CoV2373 administration, similar to myocarditis following mRNA COVID-19 vaccines and raising concern for a causal relationship to NVX-CoV2373. Events of lymphadenopathy were infrequent but reported by a higher proportion of participants in the NVX arm, with the highest rate observed after Dose 2 (0.2%). Review of the data also identified small imbalances in certain thromboembolic events, including cardiac […]
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