Clover reveals positive data from Phase II/III COVID-19 vaccine trial
pharmafile | January 21, 2022 | News story | Medical Communications |
Clover Biopharmaceuticals has announced that final efficacy data from SPECTRA, a global Phase II/III clinical trial into its COVID-19 vaccine candidate, has been published in The Lancet.
The SPECTRA trial evaluated the efficacy, safety, and immunogenicity of its COVID-19 vaccine, SCB-2019. SCB-2019 achieved the primary efficacy endpoint and secondary efficacy endpoints. The COVID-19 vaccine candidate also demonstrated 100% efficacy against severe COVID-19 and hospitalisation caused by any strain of SARS-CoV-2 in SPECTRA. The vaccine demonstrated a favourable safety profile with no significant differences observed in systemic adverse events or severe adverse events when compared to placebo.
SCB-2019 is anticipated to potentially be one of the first protein-based COVID-19 vaccines commercialised globally through the COVAX Facility.
Clover is currently in the process of submitting conditional regulatory approval applications to the NMPA, EMA, and WHO, and the company plans to commence product launch following regulatory approval.
“We are pleased to have the SPECTRA pivotal Phase II/III trial results for Clover’s COVID-19 vaccine candidate peer-reviewed and selected for publication in The Lancet,” stated Dr Ralf Clemens, Chairman of the Vaccine Scientific Advisory Board of Clover Biopharmaceuticals. “SCB-2019 (CpG 1018/Alum) demonstrated high efficacy in an environment where all of the sequenced strains were variants, and no cases of the original SARS-CoV-2 strain were observed. Combined with a favourable safety and reactogenicity profile, Clover’s vaccine candidate utilising well-established protein-based technology may help to overcome vaccine hesitancy and also warrants its further evaluation as a potential universal COVID-19 booster vaccine. Clover remains committed to making SCB-2019 (CpG 1018/Alum) available as quickly as possible to populations in need around the world.”
Lina Adams
