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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 and neurovascular events, hypersensitivity events, cholecystitis, uveitis, cardiac failure, and cardiomyopathy,” according to the documents.
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“Data from passive surveillance during post-authorization use in other countries also indicate a higher-than-expected rate of myocarditis and pericarditis (mainly pericarditis) associated with the vaccine,” the documents stated.
More from Biospace : The documents were released ahead of a June 7 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee. The agency indicated five of the six myocarditis/pericarditis cases were observed within two weeks of administration and four were in young men. There were almost 30,000 participants in the study, run between December 2020 and September 2021. Otherwise, overall efficacy was 90.4%, although lower, 78.6%, in people 65 years and older. Data from the studies were prior to […]
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