Last reviewed · How we verify
Novavax
Novavax is a Biologic drug developed by Murdoch Childrens Research Institute. It is currently in Phase 3 development.
Novavax, Inc. is a company based in Gaithersburg, Maryland that develops vaccines to counter infectious diseases, including COVID-19, influenza, and RSV. The company's COVID-19 vaccine is commercialized by Sanofi, and it is also involved in the COVID-19 Vaccines Safety Tracking (CoVaST) global consortium study.
-
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 | Novavax |
|---|---|
| Sponsor | Murdoch Childrens Research Institute |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- COVID-19 Reactogenicity (PHASE4)
- Evaluating Safety and Immune Response of Janssen, Moderna, Pfizer/BNT, and Novavax COVID-19 Vaccines for Same and Mixed Boosters in Adolescents and Adults Aged 12-64 With and Without HIV in Kenya, DRC, and Rwanda (PHASE2)
- The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection (PHASE4)
- COVID-19 Booster Study in Healthy Adults in Australia (PHASE3)
- Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study (PHASE4)
- Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed Populations (PHASE2)
- A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine (PHASE3)
- Phase 3 Study of Novavax Vaccine(s) as Booster Dose After mRNA Vaccines (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:
- Novavax CI brief — competitive landscape report
- Novavax updates RSS · CI watch RSS
- Murdoch Childrens Research Institute portfolio CI
Frequently asked questions about Novavax
What is Novavax?
Who makes Novavax?
What development phase is Novavax in?
Related
- Manufacturer: Murdoch Childrens Research Institute — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing