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AstraZeneca/Fiocruz
AstraZeneca/Fiocruz is a Viral vector vaccine Biologic drug developed by D'Or Institute for Research and Education. It is currently in Phase 3 development for COVID-19 prevention in adults and adolescents.
This is the AstraZeneca/Fiocruz COVID-19 vaccine (ChAdOx1 nCoV-19, Covishield), which uses a replication-deficient chimpanzee adenovirus vector carrying the SARS-CoV-2 spike protein gene to induce immune responses.
AstraZeneca/Fiocruz is conducting an immunogenicity study of their Covid-19 (recombinante) vaccine with varying intervals between doses. The vaccine is a glucagon-like peptide 1 receptor agonist, a type of protein-based drug.
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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 | AstraZeneca/Fiocruz |
|---|---|
| Sponsor | D'Or Institute for Research and Education |
| Drug class | Viral vector vaccine |
| Target | SARS-CoV-2 spike protein |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine delivers genetic instructions for the SARS-CoV-2 spike protein via a modified adenovirus vector that cannot replicate in human cells. This triggers both cellular and humoral immune responses, generating T-cell and antibody-mediated immunity against the spike protein. The approach allows rapid production and distribution while maintaining a strong safety profile.
Approved indications
- COVID-19 prevention in adults and adolescents
Common side effects
- Injection site pain
- Fatigue
- Headache
- Myalgia
- Fever
- Chills
Key clinical trials
- Immunogenicity Study of the Covid-19 (Recombinante) Vaccine With a 4 or 8 Week Interval Between the First Doses. (PHASE4)
- 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)
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:
- AstraZeneca/Fiocruz CI brief — competitive landscape report
- AstraZeneca/Fiocruz updates RSS · CI watch RSS
- D'Or Institute for Research and Education portfolio CI
Frequently asked questions about AstraZeneca/Fiocruz
What is AstraZeneca/Fiocruz?
How does AstraZeneca/Fiocruz work?
What is AstraZeneca/Fiocruz used for?
Who makes AstraZeneca/Fiocruz?
What drug class is AstraZeneca/Fiocruz in?
What development phase is AstraZeneca/Fiocruz in?
What are the side effects of AstraZeneca/Fiocruz?
What does AstraZeneca/Fiocruz target?
Related
- Drug class: All Viral vector 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 in adults and adolescents
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing