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Varicella zoster vaccine (live/attenuated)

Generic Name
Varicella zoster vaccine (live/attenuated)
Brand Names
Proquad, Varivax, Zostavax
Drug Type
Biotech
Unique Ingredient Identifier
GPV39ZGD8C

Overview

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 vaccine. 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 . 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 . 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% . 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.

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

  • Herpes Zoster
  • Varicella Zoster Virus Infection

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/29
Phase 4
Completed
2025/05/23
Phase 4
Completed
2025/03/24
Phase 4
Not yet recruiting
2025/02/13
Phase 3
Recruiting
2025/02/13
Phase 3
Recruiting
2024/12/16
Phase 3
Recruiting
2024/07/03
Phase 4
ENROLLING_BY_INVITATION
2024/07/01
N/A
Not yet recruiting
2024/03/18
Phase 3
Completed
2019/11/19
Phase 4
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
5/19/2006

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
VARILRIX HSA-FREE varicella vaccine live attenuated 0.5mL powder for injection vial
234752
Medicine
A
4/16/2015
VARIVAX REFRIGERATED varicella virus vaccine live powder for injection vial
90140
Medicine
A
1/3/2003
PROQUAD measles, mumps, rubella, varicella live virus vaccine injection vial with sterile diluent vial composite pack
337388
Medicine
A
8/12/2020
VARIVAX REFRIGERATED varicella virus vaccine live powder for injection vial with prefilled diluent syringe
115008
Medicine
A
3/16/2005
VARIVAX REFRIGERATED varicella virus vaccine live powder for injection vial with sterile diluent vial
337387
Medicine
A
7/30/2020
VARILRIX HSA-FREE varicella vaccine live attenuated 0.5mL injection vial plus diluent ampoule composite pack
234751
Medicine
A
4/16/2015
PROQUAD measles, mumps, rubella, varicella live virus vaccine injection vial with prefilled diluent syringe
126157
Medicine
A
2/8/2007
PROQUAD measles, mumps, rubella, varicella live virus vaccine injection vial
126153
Medicine
A
2/8/2007
PRIORIX-TETRA Vaccine 0.5mL powder for injection vial with diluent syringe
107286
Medicine
A
11/16/2005
VARILRIX HSA-FREE varicella vaccine live attenuated 0.5mL injection vial plus diluent syringe composite pack
234750
Medicine
A
4/16/2015

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