Invivyd Aligns with FDA on LIBERTY Phase 3 Trial: Evaluating VYD2311 vs. mRNA COVID Vaccine

Invivyd has received FDA guidance on its LIBERTY Phase 3 trial, which will assess the safety and immunology of VYD2311, a vaccine alternative monoclonal antibody candidate for COVID-19 prevention, versus mRNA COVID vaccines. The trial will also explore co-administration of VYD2311 and mRNA COVID vaccine. The FDA requested specific monitoring of adverse events of special interest relevant to mRNA COVID vaccines, citing the known risk of myocarditis/pericarditis in the young adult population following mRNA COVID vaccination. No similar requests have been made for other Invivyd clinical trials without an mRNA COVID vaccine arm.