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ZOSTAVAX™ (Nonconcomitant)
ZOSTAVAX™ (Nonconcomitant) is a Live attenuated vaccine Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Prevention of herpes zoster (shingles) in adults aged 50 years and older.
ZOSTAVAX is a live attenuated vaccine that stimulates the immune system to prevent herpes zoster (shingles) by boosting varicella-zoster virus (VZV)-specific cell-mediated immunity.
ZOSTAVAX is a vaccine component that induces an immune response, used to prevent Herpes Zoster. It is administered nonconcurrently, meaning it is given separately from other vaccines.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | ZOSTAVAX™ (Nonconcomitant) |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Live attenuated vaccine |
| Target | Varicella-zoster virus (VZV) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains a weakened live strain of varicella-zoster virus that replicates in the host, triggering both cellular and humoral immune responses. This immune activation provides protection against reactivation of latent VZV in individuals with prior chickenpox infection. The 'nonconcomitant' designation indicates the vaccine should not be administered simultaneously with certain other vaccines.
Approved indications
- Prevention of herpes zoster (shingles) in adults aged 50 years and older
Common side effects
- Injection site erythema
- Injection site swelling
- Injection site pain
- Headache
- Myalgia
Key clinical trials
- Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062) (PHASE3)
- A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011) (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:
- ZOSTAVAX™ (Nonconcomitant) CI brief — competitive landscape report
- ZOSTAVAX™ (Nonconcomitant) updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about ZOSTAVAX™ (Nonconcomitant)
What is ZOSTAVAX™ (Nonconcomitant)?
How does ZOSTAVAX™ (Nonconcomitant) work?
What is ZOSTAVAX™ (Nonconcomitant) used for?
Who makes ZOSTAVAX™ (Nonconcomitant)?
What drug class is ZOSTAVAX™ (Nonconcomitant) in?
What development phase is ZOSTAVAX™ (Nonconcomitant) in?
What are the side effects of ZOSTAVAX™ (Nonconcomitant)?
What does ZOSTAVAX™ (Nonconcomitant) target?
Related
- Drug class: All Live attenuated vaccine drugs
- Target: All drugs targeting Varicella-zoster virus (VZV)
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Prevention of herpes zoster (shingles) in adults aged 50 years and older
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing