Quick answers
- What is Vaccinia immune globulin intravenous (human) used for?
- The FDA-approved label (Cnj-016, Emergent BioSolutions Canada Inc., December 16, 2025) says: “VIGIV (vaccinia immune globulin intravenous, human) is indicated for the treatment and/or modification of the following conditions: • Eczema vaccinatum • Progressive vaccinia • Severe generalized vaccinia • Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Vaccinia immune globulin intravenous (human) have a boxed warning?
- Yes. The FDA label for Cnj-016 has a boxed warning (“WARNING: INTERACTIONS WITH GLUCOSE MONITORING SYSTEMS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Vaccinia immune globulin intravenous (human)?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Vaccinia immune globulin intravenous (human) been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Vaccinia immune globulin intravenous (human)?
- 1 company lists prescription products of Vaccinia immune globulin intravenous (human) in the FDA NDC Directory, including Emergent BioSolutions Canada Inc..
What Vaccinia immune globulin intravenous (human) is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VIGIV (vaccinia immune globulin intravenous, human) is indicated for the treatment and/or modification of the following conditions: • Eczema vaccinatum • Progressive vaccinia • Severe generalized vaccinia • Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy …
— FDA label: Cnj-016, Emergent BioSolutions Canada Inc., effective December 16, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: INTERACTIONS WITH GLUCOSE MONITORING SYSTEMS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Cnj-016 |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Emergent BioSolutions Canada Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125109 | — | Date not on file | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1922329, 1922334 |
|---|---|
| SPL set ID of the quoted label | a4f9f620-e6e4-4a03-a9a7-79007c8c2cfe |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125109 |
| Active ingredients (FDA) | HUMAN VACCINIA VIRUS IMMUNE GLOBULIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cnj-016, Emergent BioSolutions Canada Inc., effective December 16, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →