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Covishield
Covishield is a Biologic drug developed by Bharat Biotech International Limited. It is currently in Phase 3 development.
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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).
| 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 | Covishield |
|---|---|
| Sponsor | Bharat Biotech International Limited |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Safety and Immunogenicity of a Chimeric Recombinant Covid19 Vaccine SpiN-Tec MCTI UFMG (PHASE1, PHASE2)
- Investigating a Vaccine Against COVID-19 (PHASE2, PHASE3)
- Mix and Match of the COVID-19 Vaccine for Safety and Immunogenicity (PHASE2)
- A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older (PHASE3)
- A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults (PHASE3)
- Characterization and Durability of COVID-19 Vaccine Induced Immune Responses in Healthcare/Frontline Workers
- Adaptive Immune Response to COVID-19 Vaccination
- Phase 3 Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose (PHASE3)
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:
- Covishield CI brief — competitive landscape report
- Covishield updates RSS · CI watch RSS
- Bharat Biotech International Limited portfolio CI
Frequently asked questions about Covishield
What is Covishield?
Who makes Covishield?
What development phase is Covishield in?
Related
- Manufacturer: Bharat Biotech International Limited — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing