Summary of the Vaccines and Related Biological Products Advisory Committee meeting held to consider evaluation of vaccine candidates for the prevention of respiratory syncytial virus disease in RSV-naïve infants.

•A preventive RSV vaccine for use in infants is an important unmet medical need.•Past studies observed vaccine-associated ERD after RSV infection in RSV-naïve infants.•Risk of vaccine-associated ERD has stalled efforts to develop new candidate vaccines.•Understanding the immunopathology of ERD has guided renewed efforts at vaccine development.•This report summarizes presentations and discussion of a recent VRBPAC meeting.