FDA Approves Prefilled Syringe Presentation of GSK’s Shingrix for Shingles Prevention

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June 17, 2025: The US Food and Drug Administration (FDA) approved a new prefilled syringe presentation of Shingrix (Recombinant Zoster Vaccine, Adjuvanted), developed by GSK for the prevention of shingles (herpes zoster). The approval follows a regulatory review of data demonstrating the comparability of the prefilled syringe to the current reconstituted format.¹

The new format removes the need for healthcare providers to manually reconstitute the vaccine before administration, offering a more convenient delivery method. The vaccine’s composition, glycoprotein E antigen combined with the AS01B adjuvant system, remains unchanged.¹

Since its initial US approval in 2017, more than 90 million doses of Shingrix have been distributed across the country. It is indicated for use in adults aged 50 and older, as well as adults 18 and older at increased risk due to immunodeficiency or immunosuppression.¹

Shingles, caused by the reactivation of varicella-zoster virus, affects approximately 1 million Americans annually. By age 50, most adults carry latent VZV, and age-related immune decline increases the risk of developing shingles.¹

Shingles, or herpes zoster, is a painful rash illness caused by reactivation of the varicella-zoster virus—the same virus responsible for chickenpox. It typically begins with tingling, pain, or itching, followed by a blistering rash on one side of the body or face that heals in 2–4 weeks. While most recover fully, the most common complication is postherpetic neuralgia (PHN), a severe, long-lasting nerve pain that affects 10–18% of shingles patients, especially older adults. Other rare but serious complications include vision loss, bacterial infections, pneumonia, encephalitis, and even death. Vaccination is recommended to reduce risk and severity.²

The new presentation supports broader access and ease of administration, aligning with GSK’s strategy to optimize delivery of preventive vaccines in aging and immunocompromised populations.¹

References

1.US FDA Approves GSK’s SHINGRIX in a Prefilled Syringe Presentation. July 17, 2025. Accessed July 17, 2025. https://www.businesswire.com/news/home/20250717301201/en/US-FDA-Approves-GSKs-SHINGRIX-in-a-Prefilled-Syringe-Presentation

2.Shingles (Herpes Zoster). CDC. Accessed July 17, 2025. https://www.cdc.gov/shingles/index.html