[5] SCB-2019 is being funded by CEPI as part of COVAX[6] and has received advanced purchase orders from GAVI for 400 million doses,[7] with production to begin in 2021.
[10] Clover expects to submit its Phase III results for approval by the World Health Organization, European Medicines Agency, and China's NMPA in the fourth quarter of 2021.
[6] In February 2021, Clover decided to proceed with the adjuvant from Dynavax for its Phase II/III trials over GlaxoSmithKline after evaluating manufacturing considerations.
[2][7] In June 2020, Phase I trial were launched to assess safety, reactogenicity, and immunogenicity at multiple dose levels with 151 participants in Perth, Australia using 2 separate adjuvants, AS03 and CpG/Alum.
[18] In March 2021, a larger combined-Phase II/III trial was launched to evaluate efficacy, immunogenicity, reactogenicity, and safety of the CpG/Alum adjuvated SCB-2019 vaccine.
[19][2] In July 2021, enrollment in the Phase II/III trials was completed with 45% of the 29,000 participants in Asia, 45% in Latin America and the rest in Europe and Africa.
[4][20] In September 2021, results published in The Journal of Infectious Diseases showed SCB-2019 induced antibodies responses up to 184 days in the Phase I trial.