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Clover SCB-2019
Clover SCB-2019 is a Recombinant protein vaccine Biologic drug developed by D'Or Institute for Research and Education. It is currently in Phase 3 development for COVID-19 prevention (SARS-CoV-2 infection).
Clover SCB-2019 is a recombinant protein vaccine candidate designed to elicit immune responses against SARS-CoV-2 by presenting stabilized spike protein trimers.
Clover SCB-2019 is a vaccine candidate that has been studied in a Phase 2 clinical trial for its immunogenicity and safety in adults. The trial, NCT04950751, evaluated the vaccine in comparison to the ChAdOx1-S COVID-19 Vaccine (Fiocruz/Oxford-AstraZeneca) and CoronaVac (Sinovac Biotech) for COVID-19.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Clover SCB-2019 |
|---|---|
| Sponsor | D'Or Institute for Research and Education |
| Drug class | Recombinant protein vaccine |
| Target | SARS-CoV-2 spike protein |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
SCB-2019 uses a recombinant trimeric spike protein platform to stimulate both cellular and humoral immunity against COVID-19. The vaccine is administered with an adjuvant to enhance immunogenicity and protective efficacy. This approach aims to generate durable antibody and T-cell responses against the coronavirus.
Approved indications
- COVID-19 prevention (SARS-CoV-2 infection)
Common side effects
- Injection site pain or erythema
- Fatigue
- Headache
- Myalgia
- Fever
Key clinical trials
- Safety and Immunogenicity Dose-finding Study of Adjuvanted SCB-2020S Vaccine in Adults (PHASE1)
- Assessment of Immunogenicity, Safety and Reactogenicity of a Booster Dose of Various COVID-19 Vaccine Platforms in Individuals Primed With Several Regimes. (PHASE3)
- An Observer-blind, Cohort Randomized, Exploratory Phase 3 Study to Evaluate the Safety and Immunogenicity of Recombinant Covid-19 Vaccine, mRNA Covid-19 Vaccine and Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine as 4th Dose in Individuals Primed/ Boosted With Various Regimens (PHASE3)
- Immunogenicity and Safety of Heterologous and Homologous Boosting With ChAdOx1-S and CoronaVac or a Formulation of SCB-2019 (COVID-19) (PHASE2)
- Immunogenicity and Safety of Adjuvanted SCB-2020S Vaccines in Adults (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Clover SCB-2019 CI brief — competitive landscape report
- Clover SCB-2019 updates RSS · CI watch RSS
- D'Or Institute for Research and Education portfolio CI
Frequently asked questions about Clover SCB-2019
What is Clover SCB-2019?
How does Clover SCB-2019 work?
What is Clover SCB-2019 used for?
Who makes Clover SCB-2019?
What drug class is Clover SCB-2019 in?
What development phase is Clover SCB-2019 in?
What are the side effects of Clover SCB-2019?
What does Clover SCB-2019 target?
Related
- Drug class: All Recombinant protein vaccine drugs
- Target: All drugs targeting SARS-CoV-2 spike protein
- Manufacturer: D'Or Institute for Research and Education — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for COVID-19 prevention (SARS-CoV-2 infection)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing