A vial labelled "Novavax COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. REUTERS/Dado Ruvic/IllustrationJune 3 - The U.S. Food and Drug Administration hasraised concerns about a possible risk of heart inflammation from Novavax Inc's
"These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines," FDA staff wrote in briefing documents released on Friday.Shares of the company fell nearly 14% after the FDA's analysis of data from the company's trial. "Based on our interpretation of all the clinical data supporting NVX-CoV2373 ... we believe there is insufficient evidence to establish a causal relationship," the company said in a statement.Novavax has said the shot, NVX-CoV2373, will play a role in driving vaccination among those who have been hesitant to get immunized and it has started an educational effort on vaccine choices.
"Based on the efficacy estimate in the clinical trial of this vaccine, it is more likely than not that the vaccine will provide some meaningful level of protection against COVID-19 due to Omicron, in particular against more severe disease," the FDA staff said.
Risk of myocarditis is negligible, much less than pfizer/moderna, where’s your mention of the tens of thousands of myocarditis cases from the Pfizer/Moderna vaccines?… poor reporting and fake news