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VARIVAX® 2016 Commercial Process
VARIVAX® 2016 Commercial Process is a Live, attenuated vaccine Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Prevention of chickenpox.
VARIVAX is a live, attenuated vaccine that stimulates an immune response against the varicella-zoster virus.
Here's a 2-sentence factual summary of the VARIVAX 2016 Commercial Process: The VARIVAX 2016 Commercial Process is a vaccine used to prevent varicella, a condition studied in clinical trials. According to ClinicalTrials.gov, this process is part of the VARIVAX vaccine, which has been evaluated for immunogenicity and safety in clinical trials, including NCT03239873.
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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. -
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 | VARIVAX® 2016 Commercial Process |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Live, attenuated vaccine |
| Modality | Biologic |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
This vaccine works by introducing a weakened form of the virus to the body, which triggers an immune response and helps to build immunity against future infections. The immune system then remembers the virus and can mount a more effective response if exposed to it again in the future.
Approved indications
- Prevention of chickenpox
Common side effects
- Injection site pain
- Fatigue
- Headache
- Fever
- Vomiting
Key clinical trials
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:
- VARIVAX® 2016 Commercial Process CI brief — competitive landscape report
- VARIVAX® 2016 Commercial Process updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about VARIVAX® 2016 Commercial Process
What is VARIVAX® 2016 Commercial Process?
How does VARIVAX® 2016 Commercial Process work?
What is VARIVAX® 2016 Commercial Process used for?
Who makes VARIVAX® 2016 Commercial Process?
What drug class is VARIVAX® 2016 Commercial Process in?
What development phase is VARIVAX® 2016 Commercial Process in?
What are the side effects of VARIVAX® 2016 Commercial Process?
Related
- Drug class: All Live, attenuated vaccine drugs
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Prevention of chickenpox
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing