Moderna discusses post-marketing data with FDA to expand Covid-19 vaccine label

Moderna announced it is working with US regulators to supply post-marketing data on its Covid-19 vaccines.

The effort aims to address the FDA's decision last year to narrow the vaccine label, limiting use to certain groups.

By providing Phase 4 data, Moderna hopes to demonstrate broader safety and efficacy, which could lead to an expanded authorization.

The company has not detailed the specific studies or timeline, but the dialogue signals ongoing commitment to maintaining the products' market presence.