MedPath

Varicella zoster vaccine (recombinant)

Generic Name
Varicella zoster vaccine (recombinant)
Brand Names
Shingrix
Drug Type
Biotech
Unique Ingredient Identifier
COB9FF6I46
Background

Recombinant zoster vaccine, manufactured as the product Shingrix by GlaxoSmithKline, is an adjuvanted non-live recombinant vaccine indicated for prevention of shingles. First approved in October 2017 by the Food and Drug Administration, Shingrix is the preferred vaccine for preventing varicella zoster infection in people aged 50 years and older, replacing Zostavax as first line therapy.

Herpes zoster, also known as shingles, is caused by a reactivation of Varicella Zoster Virus (VZV), the virus that commonly causes Chickenpox 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. 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. 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.

The main immunological component of Shingrix vaccine is glycoprotein E (gE), a protein found on the surface of varicella zoster virus (VZV). Immune exposure to gE protein stimulates the development of anti-gE antibodies, and therefore adaptive immunity to VZV. Shingrix also contains an adjuvant system, AS01B, which is intended to enhance the immunological response to the vaccine leading to longer lasting and greater immunogenicity to the herpes zoster virus .

Indication

Varicella zoster vaccine is indicated for the prevention of herpes zoster (HZ) (shingles) in adults aged 50 years and older and in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.

Associated Conditions
Herpes Zoster

GSK's Linerixibat Shows Significant Improvement in Cholestatic Pruritus for Primary Biliary Cholangitis Patients

• GSK's phase III GLISTEN trial demonstrates linerixibat significantly improves cholestatic pruritus (relentless itch) in patients with primary biliary cholangitis, addressing a major quality of life concern. • The late-breaking results were presented at the European Association for the Study of the Liver (EASL) Congress 2025, highlighting the potential for a new treatment option for this challenging symptom. • Primary biliary cholangitis is a chronic autoimmune liver disease that primarily affects women, with pruritus being one of the most debilitating symptoms impacting daily functioning and quality of life.

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.

Curevo Secures $110 Million Series B Funding to Advance Next-Generation Shingles Vaccine

• Curevo's shingles vaccine candidate amezosvatein has demonstrated strong immunogenicity with improved tolerability in Phase 2 studies, positioning it as a potential alternative to current market options. • The $110 million Series B funding round was led by Medicxi, with participation from OrbiMed, HBM Healthcare Investments, Sanofi Ventures, and existing investors to support extended Phase 2 trials in adults over 70. • Former Operation Warp Speed Chief Scientific Advisor and GSK vaccine executive Moncef Slaoui joins Curevo as Board Chair, bringing significant vaccine development expertise to the company.

Dynavax Reports Strong Growth with HEPLISAV-B Revenue Up 26% in 2024, Advances Pipeline Programs

• HEPLISAV-B achieved record net product revenue of $268.4 million in 2024, representing a 26% year-over-year growth, with market share reaching 44% in the U.S. hepatitis B vaccine market. • Dynavax expects to report top-line results from its Phase 1/2 shingles vaccine trial in Q3 2025 and plans to initiate a Phase 2 plague vaccine trial in collaboration with the U.S. Department of Defense. • The company projects HEPLISAV-B net product revenue to reach $305-325 million in 2025 and anticipates completing its $200 million share repurchase program by year-end.

Goldman Sachs Downgrades Dynavax on Competitive Pressures in Shingles and Hepatitis B Markets

• Goldman Sachs has downgraded Dynavax Technologies to Sell from Neutral, reducing price target to $12 amid growing competition in the shingles vaccine market and uncertainties around Z-1018 program. • Dynavax's HEPLISAV-B showed strong performance with preliminary 2024 net product revenue of $268 million, up 26% year-over-year, despite regulatory challenges with its four-dose regimen. • GSK's Shingrix advancement with pre-filled syringes, under FDA and EMA review, poses additional competitive challenges to Dynavax's market position.

Luzhu Biotech's Novel Herpes Zoster Vaccine Advances as NMPA Accepts Regulatory Filing

• Beijing Luzhu Biotechnology has achieved a significant regulatory milestone as China's NMPA accepts the biologics license application for its recombinant herpes zoster vaccine LZ901. • The vaccine, targeting adults aged 40 and above, has successfully met its Phase III clinical trial endpoints, positioning it as a potential new preventive option for shingles. • While the acceptance enables further regulatory evaluation, the company maintains cautious outlook regarding the ultimate development and commercialization success.

GSK Raises Five-Year Revenue Target to £40bn Following Strong Specialty Medicines Growth

• GSK reported a 3% increase in 2024 sales to £31.38bn, driven by impressive 19% growth in specialty medicines, with notable performance in HIV treatments and oncology drugs. • Despite overall growth, vaccine sales declined 4% in 2024, with further decreases projected for 2025, while core earnings per share rose 3% to 159.3p, falling short of analyst expectations. • The company has upgraded its five-year sales outlook to £40bn from £38bn, supported by a robust late-stage pipeline of 19 specialty medicines and vaccines in Phase III or registration stages.

Curevo's Amezosvatein Shows Sustained Immunogenicity and Improved Tolerability in Phase 2 Shingles Vaccine Trial

• Curevo's amezosvatein maintained non-inferior anti-gE antibody levels compared to Shingrix one year after the second dose in adults aged 50-69. • The Phase 2 trial (NCT05304351) demonstrated that amezosvatein had a statistically significant improvement in Grade 2 and 3 reactogenicity versus Shingrix. • No confirmed shingles cases were observed in the highest antigen dose arms of amezosvatein or the Shingrix arm during the post-hoc analysis. • Curevo plans to advance amezosvatein into global Phase 3 trials in 2025, targeting the multi-billion dollar shingles vaccine market.

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.

FDA Adds Guillain-Barré Syndrome Warning to Pfizer and GSK RSV Vaccines

• The FDA now requires updated safety labels for Pfizer's Abrysvo and GSK's Arexvy RSV vaccines to include a warning about Guillain-Barré Syndrome (GBS). • Postmarketing studies suggest an increased risk of GBS within 42 days following vaccination with either Abrysvo or Arexvy, particularly in adults 65 and older. • The FDA emphasizes that while the data indicates a potential increased risk of GBS, a causal relationship between the vaccines and GBS has not been established. • Despite the GBS warning, the FDA maintains that the benefits of Abrysvo and Arexvy in preventing RSV-related lower respiratory tract disease continue to outweigh the risks.

GSK's GSK'227 Receives FDA Breakthrough Therapy Designation for Relapsed Osteosarcoma

• The FDA granted Breakthrough Therapy Designation to GSK'227 for relapsed or refractory osteosarcoma after two prior lines of therapy. • The designation aims to expedite the development of GSK'227, a B7-H3-targeted antibody-drug conjugate, for this rare bone cancer. • The FDA's decision was based on promising data from the ARTEMIS-002 trial, which evaluated GSK'227 in osteosarcoma patients. • GSK'227 represents a potential new treatment option for osteosarcoma patients with limited alternatives after chemotherapy failure.
© Copyright 2025. All Rights Reserved by MedPath