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Omicron Vaccine
Omicron Vaccine is a Biologic drug developed by Pontificia Universidad Catolica de Chile. It is currently in Phase 2 development.
The Omicron vaccine, specifically the COVID-19 Variant (Omicron BA.5) mRNA Vaccine Low dose, is a vaccine component that induces an immune response to prevent SARS-CoV-2 infection and COVID-19. It is being studied in clinical trials for its safety, tolerability, and immunogenicity in preventing COVID-19 caused by the Omicron BA.2 variant.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Omicron Vaccine |
|---|---|
| Sponsor | Pontificia Universidad Catolica de Chile |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- REAl LIfe" Observational Study on the Effectiveness of Evusheld Prophylaxis Against SARS-CoV-2 Omicron Variants in Vaccine Non-responder Immunocompromised Patients
- Safety and Immunogenicity of a Booster Vaccination With an Adapted Vaccine (PHASE2, PHASE3)
- Safety and Immunogenicity of NVX-CoV2705 (PHASE3)
- Lymph Node Aspiration to Decipher the Immune Response of Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine. (NA)
- Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People (PHASE1)
- COVID-19 Booster Study in Healthy Adults in Australia (PHASE3)
- A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above (PHASE3)
- Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults (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:
- Omicron Vaccine CI brief — competitive landscape report
- Omicron Vaccine updates RSS · CI watch RSS
- Pontificia Universidad Catolica de Chile portfolio CI
Frequently asked questions about Omicron Vaccine
What is Omicron Vaccine?
Who makes Omicron Vaccine?
What development phase is Omicron Vaccine in?
Related
- Manufacturer: Pontificia Universidad Catolica de Chile — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing