Manufacturing News

Clover Biopharmaceuticals' COVID-19 vaccine study underway

Clover Biopharmaceuticals, a global clinical-stage biotechnology company, announced on Tuesday the completion of targeted enrollment of adult and elderly participants in the Spectra project, or the Study Evaluating Protective-Efficacy and Safety of Clover's Trimeric Recombinant Protein-based and Adjuvanted COVID-19 Vaccine. The study is a global pivotal Phase 2/3 clinical trial evaluating the efficacy, safety and immunogenicity of SCB-2019 (CpG 1018/Alum), Clover's COVID-19 vaccine candidate.

Spectra is a double-blind, randomized, controlled study of SCB-2019 (CpG 1018/Alum) administered in a two-dose regimen, 21 days apart. Global enrollment surpassed 29,000 adult and elderly participants, resulting in one of the most ethnically diverse COVID-19 clinical trials conducted to date, including over 45 percent of participants from Asia, 45 percent from Latin America and the remainder from Europe and Africa. Given the geographic diversity of Spectra, Clover expects to announce a robust dataset in the third quarter of 2021, including an analysis of efficacy across the major currently circulating strains of SARS-CoV-2, including variants of concern and variants of interest.

Pending positive data from Spectra, Clover plans to submit conditional regulatory approval applications to China's National Medical Products Administration, the European Medicines Agency and World Health Organization.

The adolescent (ages 12-18) subgroup in Spectra also has initiated enrollment and will complete enrollment in the third quarter of the year.

Clover continues to plan to commence product launch of SCB-2019 (CpG 1018/Alum) by the end of 2021 and recently signed an advance purchase agreement with the Global Alliance for Vaccines and Immunization, committing up to 414 million doses to the COVAX facility. Clover also expects to supply doses to countries directly via government procurement and/or bilateral supply agreements.

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