Safety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled Trial

Heath, Paul TGaliza, Eva PBaxter, David NeilBoffito, MartaBrowne, DuncanBurns, FionaChadwick, David RClark, RebeccaCosgrove, Catherine AGalloway, JamesGoodman, Anna LHeer, AmardeepHigham, AndrewIyengar, ShaliniJeanes, ChristopherKalra, Philip AKyriakidou, ChristinaBradley, Judy MMunthali, ChigomezgoMinassian, Angela MMcGill, FionaMoore, PatrickMunsoor, ImroziaNicholls, HelenOsanlou, OrodPackham, JonathanPretswell, Carol HFrancisco Ramos, Alberto SanSaralaya, DineshSheridan, Ray PSmith, RichardSoiza, Roy LSwift, Pauline AThomson, Emma CTurner, JeremyViljoen, Marianne ElizabethFries, LouisCho, IksungMcKnight, IreneGlenn, GregRivers, E JoyRobertson, AndreanaAlves, KatiaSmith, KathyToback, Seth2023-02-172023-02-172023-02-01Heath, P T, Galiza, E P, Baxter, D N, Boffito, M, Browne, D, Burns, F, Chadwick, D R, Clark, R, Cosgrove, C A, Galloway, J, Goodman, A L, Heer, A, Higham, A, Iyengar, S, Jeanes, C, Kalra, P A, Kyriakidou, C, Bradley, J M, Munthali, C, Minassian, A M, McGill, F, Moore, P, Munsoor, I, Nicholls, H, Osanlou, O, Packham, J, Pretswell, C H, Francisco Ramos, A S, Saralaya, D, Sheridan, R P, Smith, R, Soiza, R L, Swift, P A, Thomson, E C, Turner, J, Viljoen, M E, Fries, L, Cho, I, McKnight, I, Glenn, G, Rivers, E J, Robertson, A, Alves, K, Smith, K & Toback, S 2023, 'Safety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled Trial', Clinical Infectious Diseases, vol. 76, no. 3, pp. 398-407. https://doi.org/10.1093/cid/ciac8031058-4838ORCID: /0000-0002-1397-4272/work/121059556https://hdl.handle.net/2164/20093Acknowledgements The study and article were funded by Novavax. We would like to thank all the study participants for their commitment to this study. We also acknowledge the investigators and their study teams for their hard work and dedication. In addition, we would like to thank the National Institute for Health Research, representatives from the Department of Health and Social Care laboratories and NHS Digital and the members of the UK Vaccine Task Force. Editorial support was provided by Kelly Cameron of Ashfield MedComms, an Inizio company Funding This work was funded by Novavax, and the sponsor had primary responsibility for study design, study vaccines, protocol development, study monitoring, data management, and statistical analyses. All authors reviewed and approved the manuscript before submission. LF reports a position as a prior full-time employee, now contractor to Novavax re-imbursed hourly for work performed on this study and in analyses and drafting this report. IC reports providing medical writing support for this work as an employee of Novavax101042287engSDG 3 - Good Health and Well-beingCoVID-19ImmunogenicityAsymptomatic InfectionsSARS-CoV-2Vaccine efficacyR MedicineSupplementary DataRSafety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled TrialJournal article10.1093/cid/ciac803http://www.scopus.com/inward/record.url?scp=85147388710&partnerID=8YFLogxK763