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Vaccine produced in new facility
A vaccine produced in a new manufacturing facility that stimulates the immune system to prevent infectious disease, though the specific pathogen target is not specified.
At a glance
| Generic name | Vaccine produced in new facility |
|---|---|
| Sponsor | PATH |
| Drug class | vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Vaccines work by introducing an antigen (or instructions to produce one) that trains the adaptive immune system to recognize and mount a protective response against a specific pathogen. Without knowing the vaccine type or target pathogen, the exact mechanism—whether it uses live attenuated virus, inactivated virus, viral vector, mRNA, or protein subunit technology—cannot be determined. The new facility designation indicates a manufacturing location change rather than a mechanistic innovation.
Approved indications
Common side effects
- Injection site reactions (pain, erythema, swelling)
- Fever
- Fatigue
- Myalgia
Key clinical trials
- Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1) (PHASE1)
- A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults (PHASE3)
- Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine (PHASE4)
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:
- Vaccine produced in new facility CI brief — competitive landscape report
- Vaccine produced in new facility updates RSS · CI watch RSS
- PATH portfolio CI