Mike Yee's questions to Moderna Inc (MRNA) leadership • Q2 2025
Question
Mike Yee questioned what would constitute a positive readout for the CMV trial, for both vaccine efficacy and secondary endpoints, and asked about the company's dialogue with regulatory bodies like the FDA and ACIP.
Answer
President Stephen Hoge defined a positive CMV result as vaccine efficacy exceeding 49.1% and noted strong secondary endpoints would demonstrate control over viral persistence, supporting its value. He affirmed that dialogues with the FDA, CBER, and ACIP remain productive and transparent, highlighting the three recent on-time product approvals as evidence of a strong working relationship.