The U.S. Department of Health and Human Services and CDC revised the federal pediatric vaccine schedule, moving recommendations for six diseases from universal guidance to risk-based or shared clinical decision-making. The move, driven by HHS review and implemented without the agency’s traditional advisory process, prompted immediate criticism from industry groups including the Biotechnology Innovation Organization (BIO). BIO and major manufacturers warned the change could sow public confusion, reduce uptake, and undermine trust in vaccination programs. The decision also triggered legal and policy scrutiny and raised questions about downstream impacts on vaccine R&D, public health preparedness, and commercial planning across vaccine makers.