Moderna said it is in talks with the FDA to provide Phase 4 post-marketing data that could restore broader use of its COVID-19 vaccines after regulators narrowed the labels last year. The company’s update frames the next step as supplying additional real-world and follow-up evidence to address post-authorization expectations. Moderna is also working through evolving regulatory conditions that have constrained use of COVID products across segments. For investors and clinicians, the outcome could affect both vaccine portfolio value and the company’s ability to deploy data-backed label expansions tied to updated evidence requirements.