Varicella Zoster Vaccine (Live/Attenuated)

Identification

Name
Varicella Zoster Vaccine (Live/attenuated)
Commonly known or available as Varicella Zoster Vaccine (Live/Attenuated)
Accession Number
DB10318
Description

Live attenuated zoster vaccine is available as two products: Zostavax for the prevention of shingles in immunocompetent people over the age of 50, and Varivax for the prevention of chickenpox in individuals 12 months of age and older. While the two vaccines contain the same immunological components and provide protection against the same virus, Zostavax contains a higher dose and is used in older adults to prevent the development of shingles and post-herpetic neuralgia.

First approved in May 2006 by the Food and Drug Administration, Zostavax was the first vaccine available for the prevention of shingles. Since October 2017, however, it has been replaced as first line therapy by Shingrix (Varicella Zoster Vaccine (Recombinant)), a more effective and longer lasting vaccine3. Both Varivax and Zostavax are composed of a lyophilized preparation of live, attenuated Oka/Merck strain of varicella-zoster virus.

Varicella Zoster Virus (VZV) is the virus that commonly causes Chickenpox (also known as Varicella) in childhood 4. Following initial infection of VZV and resolution of Chickenpox as a child, VZV then lies dormant within the dorsal root ganglion of the central nervous sytem. Decades later, when the body's immune system weakens with age, VZV is able to reactivate and descend through the nerve cells to the surface of the skin where it causes a painful blistering rash, known as shingles (or Herpes Zoster). Risk factors for developing shingles include old age, with rates increasing substantially in person's over the age of 50, low immune function or immunosuppression, psychological stress, and diabetes. Person's living with HIV or cancer, those taking immunosuppressants, and transplant recipients are particularly at risk 2.

One of the most common complications associated with shingles is the development of Post-Herpetic Neuralgia (PHN), a persistant severe nerve pain that develops as a result of chronic pain from shingles lesions. PHN can last for days, months, or even years following resolution of shingles. Other complications also include bacterial infection, spread of the shingles rash to the eye (herpes zoster ophthalmicus) or ear, nerve palsies, or spread of VZV to non-immune persons via contact with varicella lesions.

There are numerous advantages to using Shingrix over Zostavax. Clinical trials for Shingrix have shown greater than 90% efficacy in adults aged 50 and older, with 89% efficacy in preventing postherpetic neuralgia in patients 70 years and older and 91% efficacy in patients 50-70 years of age. This is a significant improvement over its predecessor, Zostavax, which reduces the risk of shingles by only 51% and the risk of post-herpetic neuralgia by 67% 1. Efficacy of Zostavax also wanes over time, with protection against shingles and PHN lasting only around 5 years. Efficacy for prevention of shingles is highest in patients 60-69 years old and decreases with increasing age. Furthermore, because Shingrix is an inactivated vaccine it can also be used to prevent shingles and PHN in individuals with suppressed immune systems, who are already at increased risk of developing shingles, while Zostavax, a live attenuated vaccine, is contraindicated.

Type
Biotech
Groups
Approved
Biologic Classification
Vaccines
Attenuated
Synonyms
  • Chickenpox vaccine
  • Human herpesvirus 3 live (attenuated) antigen
  • Varicella vaccine
  • Varicella virus vaccine live (oka-merck) strain
  • Varicella zoster live (attenuated) antigen
  • Varicella zoster live(attenuated) antigen
  • Varicella-zoster virus (live, attenuated)
  • Varicella-zoster virus strain oka/merck live (attenuated) antigen
  • Varicella-zoster virus strain oka/merck live antigen

Pharmacology

Indication

Zostavax vaccine is indicated for the prevention of herpes zoster (shingles) in immunocompetent adults aged 50 years and older.

Varivax vaccine is indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.

Associated Conditions
Contraindications & Blackbox Warnings
Learn about our commercial Contraindications & Blackbox Warnings data.
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Pharmacodynamics
Not Available
Mechanism of action

Zostavax provides protection against Herpes Zoster reactivation by eliciting an immune response to Varicella Zoster Virus (VZV).

Varivax provides protection against chickenpox by eliciting both cell-mediated and humoral immune responses to varicella-zoster virus.

Absorption
Not Available
Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half-life
Not Available
Clearance
Not Available
Adverse Effects
Learn about our commercial Adverse Effects data.
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Toxicity
Not Available
Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AbacavirThe therapeutic efficacy of Varicella Zoster Vaccine (Live/attenuated) can be decreased when used in combination with Abacavir.
AbataceptThe risk or severity of infection can be increased when Varicella Zoster Vaccine (Live/attenuated) is combined with Abatacept.
Acetylsalicylic acidThe risk or severity of adverse effects can be increased when Acetylsalicylic acid is combined with Varicella Zoster Vaccine (Live/attenuated).
AcyclovirThe therapeutic efficacy of Varicella Zoster Vaccine (Live/attenuated) can be decreased when used in combination with Acyclovir.
AdalimumabThe risk or severity of infection can be increased when Varicella Zoster Vaccine (Live/attenuated) is combined with Adalimumab.
Adefovir dipivoxilThe therapeutic efficacy of Varicella Zoster Vaccine (Live/attenuated) can be decreased when used in combination with Adefovir dipivoxil.
AldesleukinThe risk or severity of infection can be increased when Varicella Zoster Vaccine (Live/attenuated) is combined with Aldesleukin.
AlefaceptThe risk or severity of infection can be increased when Varicella Zoster Vaccine (Live/attenuated) is combined with Alefacept.
AlemtuzumabThe risk or severity of infection can be increased when Varicella Zoster Vaccine (Live/attenuated) is combined with Alemtuzumab.
AltretamineThe risk or severity of infection can be increased when Varicella Zoster Vaccine (Live/attenuated) is combined with Altretamine.
Additional Data Available
  • Extended Description
    Extended Description

    Extended description of the mechanism of action and particular properties of each drug interaction.

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  • Severity
    Severity

    A severity rating for each drug interaction, from minor to major.

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  • Evidence Level
    Evidence Level

    A rating for the strength of the evidence supporting each drug interaction.

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  • Action
    Action

    An effect category for each drug interaction. Know how this interaction affects the subject drug.

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Food Interactions
Not Available

Products

Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
VarivaxInjection, powder, lyophilized, for suspension1350 [PFU]/0.5mLSubcutaneousMerck Sharp & Dohme Corp.1995-03-17Not applicableUS flag
VarivaxInjection, powder, lyophilized, for suspension1350 [PFU]/0.5mLSubcutaneousMerck Sharp & Dohme Corp.1995-03-17Not applicableUS flag
Varivax IIIPowder, for solutionSubcutaneousMerck Ltd.2002-12-02Not applicableCanada flag
ZostavaxInjection, powder, lyophilized, for suspension19400 [PFU]/0.65mLSubcutaneousMerck Sharp & Dohme Corp.2006-05-25Not applicableUS flag
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
ProQuadVaricella Zoster Vaccine (Live/attenuated) (9772 [PFU]/0.5mL) + Measles virus vaccine live attenuated (1000 [TCID_50]/0.5mL) + Mumps virus strain B level jeryl lynn live antigen (20000 [TCID_50]/0.5mL) + Rubella virus vaccine (1000 [TCID_50]/0.5mL)Injection, powder, lyophilized, for suspensionSubcutaneousMerck Sharp & Dohme Corp.2015-07-01Not applicableUS flag
ProQuadVaricella Zoster Vaccine (Live/attenuated) (3.99 log10 tcid50/0.5mL) + Measles virus vaccine live attenuated (3 log10 tcid50/0.5mL) + Mumps virus strain B level jeryl lynn live antigen (4.3 log10 tcid50/0.5mL) + Rubella virus vaccine (3 log10 tcid50/0.5mL)Powder, for solutionSubcutaneousMerck Ltd.2014-05-09Not applicableCanada flag
ProQuadVaricella Zoster Vaccine (Live/attenuated) (9772 [PFU]/0.5mL) + Measles virus vaccine live attenuated (1000 [TCID_50]/0.5mL) + Mumps virus strain B level jeryl lynn live antigen (20000 [TCID_50]/0.5mL) + Rubella virus vaccine (1000 [TCID_50]/0.5mL)Injection, powder, lyophilized, for suspensionSubcutaneousMerck Sharp & Dohme Limited2005-09-062018-08-31US flag
VarilrixVaricella Zoster Vaccine (Live/attenuated) (2000 unit) + Water (0.5 ml)Powder, for solutionSubcutaneousGlaxosmithkline Inc2003-04-09Not applicableCanada flag

Categories

Drug Categories
Classification
Not classified

Chemical Identifiers

UNII
GPV39ZGD8C
CAS number
Not Available

References

General References
  1. Bharucha T, Ming D, Breuer J: A critical appraisal of 'Shingrix', a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus. Hum Vaccin Immunother. 2017 Aug 3;13(8):1789-1797. doi: 10.1080/21645515.2017.1317410. Epub 2017 Apr 20. [PubMed:28426274]
  2. CDC - Clinical Overview of Shingles (Herpes Zoster) [Link]
  3. CDC - What Everyone Should Know about Shingles Vaccine [Link]
  4. CDC - About Chickenpox [Link]
PubChem Substance
347910497
RxNav
1292422
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
Wikipedia
Zoster_vaccine
AHFS Codes
  • 80:12.00 — Vaccines
FDA label
Download (408 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingPreventionCartilage-hair Hypoplasia1
4Active Not RecruitingPreventionHepatitis A / Rubeola / Varicella1
4Active Not RecruitingPreventionHerpes Zoster1
4CompletedNot AvailableMumps / Rubella / Rubeola / Varicella1
4CompletedBasic ScienceShingles1
4CompletedPreventionChickenpox1
4CompletedPreventionChickenpox / Encephalitis, Japanese B1
4CompletedPreventionChickenpox / Hepatitis A / Mumps / Rubella / Rubeola1
4CompletedPreventionFibrosis / Herpes Zoster1
4CompletedPreventionFlu caused by Influenza / Respiratory Infections, Acute1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, powder, for solutionSubcutaneous10 CCID
Injection, powder, lyophilized, for solutionSubcutaneous10 CCID
Injection, powder, for suspensionIntramuscular; Subcutaneous1000 [TCID_50]/0.5mL
Injection, powder, lyophilized, for suspensionIntramuscular; Subcutaneous1000 [TCID_50]/0.5mL
Injection, powder, lyophilized, for suspensionSubcutaneous
Injection, powder, lyophilized, for suspensionIntramuscular; Subcutaneous3 log10/0.5ml
Injection, powder, for solutionSubcutaneous2000 unit
Powder, for solutionSubcutaneous
Injection, powder, lyophilized, for solutionIntramuscular103 PFU
Injection, powder, for suspensionIntramuscular; Subcutaneous1350 [PFU]/0.5mL
Injection, powder, for suspensionIntramuscular; Subcutaneous1350 PFU
Injection, powder, lyophilized, for suspensionSubcutaneous1350 [PFU]/0.5mL
SuspensionSubcutaneous1350 PFU
Powder, for solutionSubcutaneous
PowderSubcutaneous1.35 CFU
Injection, powder, for suspensionSubcutaneous19400 PFU/0.65mL
Injection, powder, lyophilized, for suspensionSubcutaneous19400 [PFU]/0.65mL
Injection, powder, lyophilized, for suspensionSubcutaneous19400 PFU/0.65mL
Injection, powder, for suspensionSubcutaneous19400 PFU
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Drug created on December 01, 2015 13:03 / Updated on October 19, 2020 07:47

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