FDA Approves Prefilled Syringe Presentation of GSK’s Shingrix for Shingles Prevention
New format eliminates reconstitution step, offering greater convenience for providers and supporting expanded access for at-risk adults.
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On June 17, 2025, the US Food and Drug Administration approved a new prefilled syringe presentation of recombinant zoster vaccine, adjuvanted (Shingrix) 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 with the current reconstituted format.1
The new format removes the need for health care 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 zoster vaccine have been distributed across the country. It is indicated for use in adults 50 years or older as well as adults at increased risk due to immunodeficiency or immunosuppression.1
Shingles, caused by the reactivation of varicella-zoster virus (VZV), 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 is a painful rash illness caused by reactivation of the VZV—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 to 4 weeks. Although most recover fully, the most common complication is postherpetic neuralgia, a severe, long-lasting nerve pain that affects 10% to 18% of patients with shingles, 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. News release. GSK plc. 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). Centers for Disease Control and Prevention. Accessed July 17, 2025. https://www.cdc.gov/shingles/index.html
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