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bOPV/IPV (6 weeks)
bOPV/IPV (6 weeks) is a Biologic drug developed by Centers for Disease Control and Prevention. It is currently in Phase 3 development for Protection against poliovirus and Haemophilus influenzae type b in infants and young children, Prevention of polio and Hib disease in individuals who have not previously been vaccinated or have not completed a full vaccination series.
bOPV/IPV is a vaccine that stimulates the body's immune response to protect against poliovirus and Haemophilus influenzae type b.
bOPV/IPV is a vaccine that stimulates the body's immune response to protect against poliovirus and Haemophilus influenzae type b. Used for Protection against poliovirus and Haemophilus influenzae type b in infants and young children, Prevention of polio and Hib disease in individuals who have not previously been vaccinated or have not completed a full vaccination series.
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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). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| 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 | bOPV/IPV (6 weeks) |
|---|---|
| Sponsor | Centers for Disease Control and Prevention |
| Modality | Biologic |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
The vaccine works by introducing inactivated poliovirus and Haemophilus influenzae type b antigens to the body, which triggers an immune response and produces antibodies to fight these pathogens. This immune response provides long-term protection against polio and Hib disease.
Approved indications
- Protection against poliovirus and Haemophilus influenzae type b in infants and young children
- Prevention of polio and Hib disease in individuals who have not previously been vaccinated or have not completed a full vaccination series
Common side effects
- Fever
- Redness, swelling, or pain at the injection site
- Irritability
Key clinical trials
- Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One Booster Dose in the Three Primary Vaccination Plus Boosting Schedule, and Protective Effect in the Schedule With Bivalent OPV in Infants (PHASE3)
- Immunogenicity of Different Primary Immunization Schedules with Inactivated Poliovirus Vaccine (IPV) Plus Pentavalent Vaccine (DTwP-HBV-Hib) or with Hexavalent Vaccine (DTwP-HBV-Hib-IPV) (PHASE4)
- A Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2 (PHASE4)
- A Study to Evaluate the Safety and Immunogenicity of Novel Oral Polio Vaccine (PHASE2)
- Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), bOPV and IPV (PHASE4)
- Monovalent Oral Poliovirus Vaccine Type 1 Intestinal and Humoral Immunity Study (PHASE4)
- Duration of IPV Priming and Antibody Decay (PHASE4)
- Use of mOPV1 in Routine Immunization in Pakistan. (NA)
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:
- bOPV/IPV (6 weeks) CI brief — competitive landscape report
- bOPV/IPV (6 weeks) updates RSS · CI watch RSS
- Centers for Disease Control and Prevention portfolio CI
Frequently asked questions about bOPV/IPV (6 weeks)
What is bOPV/IPV (6 weeks)?
How does bOPV/IPV (6 weeks) work?
What is bOPV/IPV (6 weeks) used for?
Who makes bOPV/IPV (6 weeks)?
What development phase is bOPV/IPV (6 weeks) in?
What are the side effects of bOPV/IPV (6 weeks)?
Related
- Manufacturer: Centers for Disease Control and Prevention — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Protection against poliovirus and Haemophilus influenzae type b in infants and young children
- Indication: Drugs for Prevention of polio and Hib disease in individuals who have not previously been vaccinated or have not completed a full vaccination series
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing