GSK Advances Vaccine Delivery and Hepatitis B Treatment

With the European Commission’s approval of a new prefilled syringe presentation of GSK’s recombinant zoster vaccine (brand name Shingrix), a product intended to prevent shingles in adults, the vaccine’s delivery format has been altered from a two-vial system requiring manual reconstitution to a single prefilled syringe. The new prefilled syringe format streamlines the administration process for healthcare professionals, according to a Jan. 7, 2026 company announcement (1).

Shingles, caused by reactivation of the varicella-zoster virus, remains a clinical concern due to its painful manifestations and potential for complications, such as post-herpetic neuralgia (2,3). The disease affects approximately 1.7 million people in Europe annually, with increased incidence in older adults and patients with chronic comorbidities (4). According to GSK, the simplified syringe format of the vaccine removes the need for reconstitution, which traditionally involves withdrawing and mixing a lyophilized antigen and liquid adjuvant prior to injection, potentially reducing preparation time and the risk for handling errors in clinical settings (1).

“This new presentation of Shingrix has been designed to improve ease of administration, helping healthcare professionals to provide protection against shingles,” said Tony Wood, chief scientific officer, GSK, noting the design intent behind this new presentation in a company press release (1).

What does the prefilled syringe approval mean for vaccine administration?

The approval was granted based on data demonstrating technical comparability between the new prefilled syringe and the existing vaccine presentation. The change does not affect the vaccine’s indication or dosing regimen, GSK clarified in the release (1).

This approval may influence broader vaccination practices by simplifying workflows in vaccination programs and reducing the training burden associated with multi-component formulations. In an industry increasingly focused on improving both efficacy and operational efficiency, such technical refinements are an important part of vaccine deployment strategies (1).

How do Phase III trial results for bepirovirsen influence chronic hepatitis B research?

Also on Jan. 7, 2026, GSK released positive results from two pivotal Phase III studies (B-Well 1 and B-Well 2) evaluating bepirovirsen, an investigational antisense oligonucleotide (ASO), as a treatment for chronic hepatitis B (CHB). The two global, multi-center, randomized controlled trials, which enrolled more than 1800 participants across 29 countries, both met their primary endpoints, showing statistically significant and clinically meaningful improvements in functional cure rates when the ASO was added to standard of care compared with standard care alone (5).

CHB, a persistent infection affecting more than 250 million people globally, is a leading factor in liver cancer incidence (6). Current antiviral regimens typically involve long-term therapy with nucleoside/ analogues, yet a functional cure remains uncommon. A functional cure is defined by sustained loss of hepatitis B surface antigen and undetectable viral DNA (7,8).

The results of the Phase III trials suggest that bepirovirsen suppresses antigen production and can potentially enhance immune control, signaling a shift in the CHB treatment paradigm. “Bepirovirsen has the potential to transform treatment goals for people living with CHB by achieving significant functional cure rates—a first for the disease,” Wood said in a press release (5). “Today’s result supports our plans to progress bepirovirsen as a treatment and also continue its development as a backbone in future sequential therapies.”

GSK anticipates filing global regulatory submissions for the ASO starting in the first quarter of 2026. If approved, bepirovirsen could represent a finite therapeutic option for CHB and serve as a foundation for other treatment combinations (5).

Why do these developments matter in the biopharma industry?

Together, the new Shingrix presentation and bepirovirsen’s phase III outcomes reflect two different dimensions of biopharmaceutical innovation: optimization of delivery mechanisms and advancement of therapeutic modalities for chronic disease (1,5). Streamlined vaccine presentations can reduce procedural complexity and support broader uptake, while emerging antiviral treatments aim to redefine long-term clinical outcomes.

Both developments are relevant to industry stakeholders, including clinical researchers, manufacturing scientists, and healthcare professionals, as they highlight how formulation and mode of action advancements can have practical implications for patient care and health system operations (9). These updates illustrate incremental and potential transformational changes within drug development and delivery paradigms.

References

1. GSK. GSK’s Shingrix (Recombinant Zoster Vaccine) Prefilled Syringe Presentation Approved by the European Commission. Press Release. Jan. 7, 2026.
2. Harpaz, R.; Ortega-Sanchez, I. R.; Seward, J. F. Prevention of Herpes Zoster: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2008, 57 (RR-5), 1–30.
3. Mueller, N. H.; Gilden, D. H.; Cohrs, R. J.; et al. Varicella Zoster Virus Infection: Clinical Features, Molecular Pathogenesis of Disease, and Latency. Neurologic Clinics 2008, 26 (3), 675–697. DOI: 10.1016/j.ncl.2008.03.011
4. Pinchinat, S.; Cebrián-Cuenca, A. M.; Bricout, H.; Johnson, R. W. Similar Herpes Zoster Incidence Across Europe: Results from a Systematic Literature Review. BMC Infect. Dis. 2013, 3, 170. DOI: 10.1186/1471-2334-13-170
5. GSK. GSK Announces Positive Results from B-Well 1 and B-Well 2 Phase III Trials for Bepirovirsen, a Potential First-in-Class Treatment for Chronic Hepatitis B. Press Release. Jan. 7, 2026.
6. WHO. Global Hepatitis Report 2024: Action for Access in Low- and Middle-Income Countries. Global Report. April 9, 2024.
7. Slaets, L.; De Ridder, F.; Lenz, O. Systematic Review with Meta-Analysis: Hepatitis B Surface Antigen Decline and Seroclearance in Chronic Hepatitis B Patients on Nucleos(t)ide Analogues or Pegylated Interferon Therapy. GastroHep. April 14, 2020. DOI: 10.1002/ygh2.393
8. Cornberg, M.; Sandmann, L.; Jaroszewicz, J.; et al. EASL Clinical Practice Guidelines on the Management of Hepatitis B Virus Infection. J. Hepatol. 2025, 83 (2), 502–583. DOI: 10.1016/j.jhep.2025.03.018
9. Kaur, T.; Dushyant, Sharma, T.; Dhingra, A. K. Technological Advancements in Drug Formulation and Delivery: Revolutionizing Therapeutic Outcomes. Curr. Pharm. Des. Oct. 28,2025. DOI: 10.2174/0113816128388316251001042422