Gustavo H Dayan, Nadine Rouphael, Stephen R Walsh, Aiying Chen, Nicole Grunenberg, Mary Allen, Johannes Antony, Kwaku Poku Asante, Amit Suresh Bhate, Tatiana Beresnev, Matthew I Bonaparte, Médéric Celle, Maria Angeles Ceregido, Lawrence Corey, Dmytro Dobrianskyi, Bo Fu, Marie-Helene Grillet, Maryam Keshtkar-Jahromi, Michal Juraska, Jia Jin Kee, Hannah Kibuuka, Marguerite Koutsoukos, Roger Masotti, Nelson L Michael, Kathleen M Neuzil, Humberto Reynales, Merlin L Robb, Sandra M Villagómez Martínez, Fredrick Sawe, Lode Schuerman, Tina Tong, John Treanor, T Anh Wartel, Carlos A Diazgranados, Roman M Chicz, Sanjay Gurunathan, Stephen Savarino, Saranya Sridhar
BACKGROUND: COVID-19 vaccines with alternative strain compositions are needed to provide broad protection against newly emergent SARS-CoV-2 variants of concern. This study aimed to describe the clinical efficacy and safety of a bivalent SARS-CoV-2 recombinant protein vaccine as a two-injection primary series during a period of circulation of the omicron (B.1.1.529) variant. METHODS: We conducted a phase 3, parallel, randomised, modified double-blind, placebo-controlled trial in adults aged 18 years or older at 54 clinical research centres in eight countries (Colombia, Ghana, India, Kenya, Mexico, Nepal, Uganda, and Ukraine)...
September 13, 2023: Lancet Respiratory Medicine