Invivyd已收到FDA关于VYD 2311（该公司用于预防Covid-19的研究性单克隆抗体）与市售mRNA COVID疫苗的LIBERTY 3期试验的建议，并与之保持一致

2026-02-03 20:13

LIBERTY is part of the Company's broader REVOLUTION clinical program designed to elaborate the profile of monoclonal antibody-mediated prophylaxis from COVID-19 and the potential medical benefits to vulnerable Americans
The LIBERTY clinical trial will evaluate comparative safety and immunology of VYD2311 versus mRNA COVID vaccine, as well as explore the safety and immunology of co-administered VYD2311 and mRNA COVID vaccine
FDA, providing feedback jointly from CDER and CBER, requested specific monitoring of adverse events of special interest (AESIs) 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