First COVID-19 Vaccine Candidate to Demonstrate Significant Efficacy Against Delta Variant
China-based Clover Biopharmaceuticals, Ltd. and the Coalition for Epidemic Preparedness Innovations (CEPI) announced on September 22, 2021, that Clover's adjuvanted protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), achieved the primary efficacy endpoint and secondary efficacy endpoints in a global pivotal Phase 2/3 clinical trial.
Clover's COVID-19 vaccine candidate is one of the first to demonstrate significant efficacy against Delta in a double-blind, randomized clinical trial.
SCB-2019 (CpG 1018/Alum) demonstrated 79% overall efficacy against COVID-19 of any severity caused by the globally dominant Delta variant.
And this study found the efficacy was 92% against the Gamma variant and 59% against the Mu variant.
Overall efficacy was 67% against COVID-19 of any severity caused by any strain in the study, successfully meeting the trial's primary endpoint.
The SPECTRA clinical trial enrolled over 30,000 adult and elderly (≥18 years of age) participants at thirty-one sites in the Philippines, Brazil, Colombia, South Africa, Belgium, resulting in one of the most diverse COVID-19 vaccine clinical trials conducted to date.
The SPECTRA study was funded by CEPI as part of an up to $328 million investment to develop and enable equitable access to SCB-2019 (CpG 1018/Alum).
Dr. Richard Hatchett, CEO of CEPI, added, "This very encouraging data demonstrates the favorable safety profile of Clover's vaccine and its efficacy against multiple variants of SARS-CoV-2 – including the predominant Delta variant."
"So it will be a crucial addition to our weaponry in the fight against COVID-19."
"CEPI's significant early investments have accelerated the clinical development and manufacturing of the vaccine and will enable equitable access to hundreds of millions of doses through COVAX."
"As a result of CEPI's partnership with Clover, this vaccine is poised to play a significant role in protecting those most at risk from COVID-19, wherever they are in the world."
Clover Biopharmaceuticals created our COVID-19 vaccine candidate by combining SCB-2019 with Dynavax's (Nasdaq: DVAX) CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Clover is a global clinical-stage biotechnology company located in Chengdu, China, committed to developing novel vaccines and biologic therapeutic candidates.