Novavax, Inc.

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Novavax Statement On Us FDA Briefing Document Related To Myocarditis/Pericarditis

Published: 06/03/2022 17:26 GMT
Novavax, Inc. (NVAX) - Novavax Statement on US FDA Briefing Document Related to Myocarditis/pericarditis.
Novavax- Have Learned to Expect to See Natural Background Events of Myocarditis in Any Sufficiently Large Database and Young Males Are at Higher Risk.
Novavax - Based on Interpretation of All Clinical Data Supporting Nvx-cov2373, Believe There is Insufficient Evidence to Establish Causal Relationship With Myocarditis/pericarditis.
Novavax - Data From Our Placebo-controlled Studies Show That Overall the Rate of Myocarditis Was Balanced Between the Vaccine and Placebo Arms.
Novavax- in Post-crossover Portions of Studies, Myocarditis Cases Seen Are All Within Expected Rate.
Further Company Coverage: Nvaxo ((reuters.
Briefs@thomsonreuters.
Com;)).