Clover anticipates commercializing SCB-2019 (CpG 1018/Alum) as one of the first protein-based COVID-19 vaccines globally, potentially reducing the global shortage of COVID-19 vaccines and capturing a significant market share of the approximately 15 billion COVID-19 vaccine doses required through 2026. SCB-2019 (CpG 1018/Alum) is stable for at least two months at room temperature and is expected to be stable long term in refrigeration conditions. Given these factors, SCB-2019 (CpG 1018/Alum) is potentially a preferable and a more cost-effective solution for global distribution by leveraging existing and conventional infrastructure, a necessity when transporting to remote and low-resource regions.
Our Phase 1 clinical trial of SCB-2019 (CpG 1018/Alum), published in The Lancet, induced high neutralizing antibody titers and Th1-biased cell-mediated immune responses, implying a balanced immune response. SCB-2019 (CpG 1018/Alum) also demonstrated a favorable safety profile with no serious vaccine-related adverse events and few moderate-to-severe local and systemic adverse events.
Pending positive interim data from SPECTRA, we plan to submit conditional regulatory approval applications to the EMA, the NMPA and the WHO in the second half of 2021, and plan to commence product launch by the end of 2021. SCB-2019 (CpG 1018/Alum) is funded by Coalition for Epidemic Preparedness Innovations (CEPI) and will be made available for procurement and allocation through the COVAX Facility. Clover also intends to supply additional capacity of SCB-2019 (CpG 1018/Alum) post conditional approval via bilateral supply agreements with sovereign countries if COVAX does not exercise its right of first refusal to procure doses or if there is additional capacity available.
We expect to commercialize SCB-2019 (CpG 1018/Alum) globally to address the global shortage of COVID-19 vaccines and capture a significant market share of the approximately 15 billion COVID-19 vaccine doses required through 2026. To produce our vaccine candidate, we will leverage our in-house manufacturing facilities in Changxing and will potentially be able to produce more than one billion doses of SCB-2019 in-house annually at peak capacity.
Clover is well-positioned to rapidly develop second-generation COVID-19 vaccine candidates to address the emerging variants of concern by leveraging our proprietary 1. Trimer-Tag© Technology Platform. A pre-clinical immunogenicity study in mice indicated that our monovalent South Africa Variant (B.1.351 variant of SARS-CoV-2)-based vaccine candidate could potentially be broadly protective against the currently circulating original SARS-CoV-2 strains and variants of concern.
Clover is conducting additional vaccine discovery programs for various other indications, including rabies, RSV, influenza, and HIV, all of which are enveloped RNA viruses that display trimeric spike glycoproteins, a characteristic similar to the SARS-CoV-2 virus.