An internal memo from CBER director Vinay Prasad outlining a proposed overhaul of U.S. vaccine approval policy became public, triggering market and industry reaction. The document recommends higher evidentiary standards — including randomized data and population‑specific trials — for future vaccines and questions pandemic‑era regulatory shortcuts. The memo’s public release prompted a sell‑off in vaccine developers’ stocks as investors priced in longer development timelines, higher study costs and narrower paths to label expansion. Industry analysts and company statements flagged the potential downstream effects on pediatric and seasonal vaccine programs. Regulators and advisory committees will now face heightened scrutiny over whether the proposed framework will raise safety and efficacy standards or slow access to updated vaccines.