Moderna COVID Vaccine’s Myocarditis Risk Has Improved With Time, US FDA Says

14 Jun 2022

‘Robust results’ from recent US surveillance studies show slight decreases in the myocarditis risk differential between the Moderna and Pfizer/BioNTech vaccines, agency says in briefing documents for panel review of Moderna’s pediatric EUA request.

Hour glass — The myocarditis risk differential for Moderna's vaccine relative to Pfizer/BioNTech's is looking better with the passage of time and more surveillance data. • Source: Shutterstock

The US Food and Drug Administration appears more comfortable with the myocarditis risk of Moderna, Inc.’s COVID-19 vaccine relative to that of Pfizer Inc./BioNTech SE’s competing mRNA product in adolescent males and young men than it did in the second half of 2021.

Briefing documents released ahead of a two-day meeting of the Vaccines and Related Biological Products Advisory Committee, which will...