MedPath

Varicella zoster vaccine (live/attenuated)

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

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
Related News

Shingles Vaccine Reduces Cardiovascular Risk by 23% for Up to Eight Years, Study Finds

• A large-scale study of over 1.2 million people found that receiving a shingles vaccine is associated with a 23% lower risk of cardiovascular events, with protection lasting up to eight years. • The protective effect was strongest in men, individuals under 60, and those with unhealthy lifestyles, with a 26% reduction in major cardiovascular events including stroke, heart attack, and death from heart disease. • Researchers suggest the vaccine may prevent cardiovascular complications by reducing shingles-related blood vessel damage, inflammation, and clot formation that can contribute to heart disease.

GSK Launches Landmark Study to Investigate Shingles Vaccine's Potential to Reduce Dementia Risk

• British pharmaceutical company GSK is initiating a groundbreaking four-year study using data from up to 1.4 million NHS patients to determine if its Shingrix vaccine reduces dementia risk. • Previous research suggests the shingles vaccine may lower dementia risk by up to 27%, with a Stanford Medicine study finding vaccinated Welsh adults were 20% less likely to develop dementia over seven years. • If confirmed, this could represent a significant breakthrough in dementia prevention using an existing vaccine already administered through the NHS to adults aged 65 and older.

GSK's Shingrix Prefilled Syringe Under Review by FDA and EMA for Shingles Prevention

• The FDA and EMA are reviewing GSK's application for a Shingrix prefilled syringe, potentially streamlining vaccine administration. • The new syringe formulation aims to simplify the vaccination process by removing the need for reconstitution. • Shingrix is a recombinant zoster vaccine indicated for the prevention of shingles in adults, with over 90 million doses distributed in the US since 2017. • Clinical data supports the comparability of the prefilled syringe to the existing reconstituted vaccine, ensuring consistent efficacy.

Sinovac Launches Phase III Trial of Bivalent HFMD Vaccine

• Sinovac Biotech has initiated a Phase III clinical trial for its bivalent vaccine targeting Hand Foot and Mouth Disease (HFMD). • The trial will assess the vaccine's efficacy, safety, and immunogenicity in infants and young children aged 6 to 71 months. • This marks the first Phase III trial globally for a multivalent vaccine against HFMD, caused by Enterovirus 71 (EV71) and Coxsackievirus 16 (CA16). • Sinovac is also developing a tetravalent vaccine against HFMD, expanding protection against additional enterovirus strains.

Shingles Vaccination Rates Show Significant Rise Among Asthma Patients, Study Reveals Major Disparities

• Shingles vaccination rates among asthma patients increased dramatically from 6.1% in 2008 to 42.8% in 2023, with an average annual increase of 13.48% according to a comprehensive national survey. • Research analyzing data from over 20,000 individuals revealed that asthma patients face a 95% higher risk ratio for developing shingles, highlighting the importance of preventive vaccination. • Despite overall improvement in vaccination rates, significant disparities persist across age, sex, race/ethnicity, income, and education levels, calling for targeted interventions to improve access.

Shingles Vaccination Shows Dual Benefit: Virus Prevention and Cardiovascular Protection

• Recent research reveals individuals with shingles face a 30% higher risk of cardiovascular events, highlighting an unexpected connection between the varicella-zoster virus and vascular health. • Clinical trials demonstrate Shingrix vaccine's remarkable effectiveness, showing 97% efficacy in preventing shingles for adults aged 50-69 and 91% for those 70 and older. • The varicella-zoster virus is uniquely identified as the only human virus known to replicate in arteries, leading to vasculopathy and potentially increased stroke risk by 38%.

Shingrix Vaccine Shows Strong Protection Against Shingles in IBD Patients, Mayo Clinic Study Finds

• A new study reveals that IBD patients who received two doses of Shingrix vaccine showed significantly lower shingles risk (1.09%) compared to unvaccinated controls (2.4%). • The vaccine demonstrated effectiveness across all age groups and both forms of IBD (ulcerative colitis and Crohn's disease), supporting CDC recommendations for immunocompromised adults. • Cost-effectiveness analysis shows Shingrix vaccination is economically beneficial for Crohn's disease patients over 30 and ulcerative colitis patients over 40, with favorable quality-adjusted life year outcomes.

Rare Shingles Reactivation Reported Post-Shingrix Vaccination

• A recent study highlights a rare case of herpes zoster ophthalmicus (HZO) reactivation following recombinant zoster vaccine (RZV) administration in a 59-year-old male. • The patient developed a rash and paresthesia nine days post-vaccination, requiring hospitalization and treatment with valacyclovir and mupirocin. • While RZV (Shingrix) is generally safe and effective, this case underscores the need for ongoing monitoring for potential adverse events and rare reactivation. • Further research is necessary to understand how RZV's immunomodulatory effects may, in rare instances, provoke herpes zoster reactivation.

Curevo's Amezosvatein Shows Promise in Phase 2 Trial with Improved Tolerability for Shingles Vaccine

• Curevo Vaccine's amezosvatein demonstrated non-inferiority to Shingrix in a Phase 2 trial, meeting all primary endpoints for immunogenicity. • The trial, involving 876 participants, showed amezosvatein had a 100% vaccine response rate compared to Shingrix's 97.9%. • Amezosvatein exhibited lower rates of local and systemic adverse events, suggesting improved tolerability over the existing Shingrix vaccine. • Curevo plans to advance amezosvatein into global Phase 3 trials in 2024, targeting the $4 billion shingles vaccine market.

Shingrix Label Updated with Guillain-Barré Syndrome Warning Following FDA Review

• The FDA has mandated a label update for Shingrix, a shingles vaccine, to include a warning about the potential risk of Guillain-Barré Syndrome (GBS). • Postmarketing studies revealed an elevated risk of GBS within 42 days following Shingrix vaccination, particularly after the first dose, in adults aged 65 and older. • The FDA emphasizes that while an association between Shingrix and GBS was observed, the available evidence is insufficient to establish a definitive causal relationship. • Healthcare professionals in Hong Kong will be informed, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy