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Varilrix HSA-free
Varilrix HSA-free is a Live attenuated vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Prevention of varicella (chickenpox) in children and adults.
Varilrix HSA-free is a live attenuated varicella-zoster virus vaccine that stimulates immune response to prevent varicella (chickenpox) infection.
Varilrix HSA-free is a live attenuated varicella-zoster virus vaccine that stimulates immune response to prevent varicella (chickenpox) infection. Used for Prevention of varicella (chickenpox) in children and adults.
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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
GlaxoSmithKline 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 | Varilrix HSA-free |
|---|---|
| Sponsor | GlaxoSmithKline |
| 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 form of the varicella-zoster virus that replicates in the body without causing disease, thereby priming both cellular and humoral immunity against the virus. The HSA-free formulation removes human serum albumin from the vaccine composition. This allows the immune system to recognize and respond to varicella-zoster virus antigens, providing protection against natural infection.
Approved indications
- Prevention of varicella (chickenpox) in children and adults
Common side effects
- Injection site reactions (erythema, swelling, pain)
- Fever
- Rash
- Myalgia
Key clinical trials
- A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age. (PHASE3)
- Study of Two Formulations of GSK Biologicals' Varicella Vaccine (PHASE2)
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:
- Varilrix HSA-free CI brief — competitive landscape report
- Varilrix HSA-free updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Varilrix HSA-free
What is Varilrix HSA-free?
How does Varilrix HSA-free work?
What is Varilrix HSA-free used for?
Who makes Varilrix HSA-free?
What drug class is Varilrix HSA-free in?
What development phase is Varilrix HSA-free in?
What are the side effects of Varilrix HSA-free?
What does Varilrix HSA-free target?
Related
- Drug class: All Live attenuated vaccine drugs
- Target: All drugs targeting Varicella-zoster virus (VZV)
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Prevention of varicella (chickenpox) in children and adults
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing