A Reanalysis of the FDA's Benefit-Risk Assessment of Moderna's mRNA-1273 COVID Vaccine Based on a Model Incorporating Benefits Derived from Prior COVID Infection.

ABSTRACT:

Background

The U.S. Food and Drug Administration (FDA) conducted a benefit-risk assessment for Moderna's COVID vaccine mRNA-1273 prior to its full approval, announced 31 January 2022. The FDA's assessment focused on males 18-64 years old because its risk analysis was limited to vaccine-attributable myocarditis/pericarditis (VAM/P), given the excess risk among males. The FDA's analysis concluded that vaccine benefits outweighed risks, even for 18-25-year-old males (those at highest VAM/P risk). We reanalyze the FDA's benefit-risk assessment using information available through the third week of January 2022 and focusing on 18-25-year-old males.

Methods

We develop a benefit-risk model, extending the FDA's, that can stratify benefits and risks of vaccination by prior-infection a

SUBMITTER: Bourdon PS 

PROVIDER: S-EPMC12945011 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature