Efficacy and Safety of NVX-CoV2705

This is a Phase 4, multicenter, randomized, double-blind, placebo-controlled, post-marketing study to evaluate the efficacy and safety of a single dose of an Omicron JN.1 subvariant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M (NVX-CoV2705) in adults 50 to \< 65 years of age who are not considered to be at high risk of severe coronavirus disease 2019 (COVID-19). This study will be conducted in the United States (US). Approximately 6,500 participants will be randomized in a 1:1 ratio via block randomization to receive a single intramuscular (IM) injection of NVX-CoV2705 or placebo (normal saline) on Day 0 and remain on study for efficacy and safety data collection through Day 180/end of study (EoS).