FDA Approves GSK’s Shingles Vaccine in Prefilled Syringe

The FDA has approved a prefilled syringe format of the recombinant zoster vaccine Shingrix for the prevention of shingles, GSK said in a release.¹ The company said approval of the new presentation was based on data that showed comparability between the new and existing version of the vaccine.

FDA Approves GSK’s Shingles Vaccine in Prefilled Syringe / Rido - stock.adobe.com

Currently, Shingrix is available as a vial of a lyophilized antigen and a vial of liquid adjuvant that must be combined prior to administration. The new vaccine presentation, which is approved for the same indications, will make the process easier because it does need to be reconstituted before giving it to a patient.

“The prefilled syringe presentation of GSK’s shingles vaccine is good news, providing a convenient method of administration,” Brigid Groves, PharmD, MS, vice president of professional affairs at the American Pharmacists Association, said in a release.¹ “The FDA approval is a positive step toward driving prevention of this painful disease, and as a practicing pharmacist I welcome the availability of this new presentation.”

Shingrix was initially approved by the FDA in 2017 for the prevention of shingles in adults aged 50 years or older.² The vaccine then received approval in 2021 for the prevention of shingles in adults aged 18 years or older who have an increased risk of shingles infection due to immunodeficiency or immunosuppression.³

The first approval of Shingrix was based on data from a phase 3 clinical trial program, which included the ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) studies. The ZOE-50 and ZOE-70 trials included a total of nearly 30000 patients who received 2 doses of Shingrix or a placebo 2 months apart. The studies found the vaccine demonstrated an efficacy of more than 90% against shingles across all age groups. The vaccine also sustained efficacy over 4 years of follow-up.

The approval of the second indication was based on data that examined the safety and efficacy of Shingrix in adult patients who had undergone an autologous hematopoietic stem cell transplant and those undergoing treatment for hematological malignancies. The approval made Shingrix the first shingles vaccine approved for use in adults 18 years or older who have immunodeficiency or immunosuppression.

“At GSK, we are committed to advancing scientific innovation and delivering practical solutions that address the needs of the healthcare community,” Tony Wood, PhD, chief scientific officer at GSK, said in a release.¹ “This new presentation of Shingrix was developed to streamline the vaccination process, supporting healthcare professionals to provide protection against shingles, a disease that 1 in 3 US adults will develop in their lifetime.”

Shingles, or herpes zoster, affects about 1 in 3 people in the United States during their lifetime, with risk increasing with age or a weakened immune system. While most experience shingles only once, recurrence is possible. The most common complication is postherpetic neuralgia, affecting 10% to 18% of cases, particularly among older adults. Hospitalization occurs in 1% to 4% of cases, mostly involving immunocompromised individuals. Though shingles-related deaths are rare (fewer than 100 annually), they primarily affect older or immunosuppressed individuals. After decades of rising rates, shingles incidence has recently plateaued or declined.⁴

READ MORE: Immunization Resource Center

Ready to impress your pharmacy colleagues with the latest drug information, industry trends, and patient care tips? Sign up today for our free Drug Topics newsletter.

References

1. US FDA approves GSK’s Shingrix in a prefilled syringe presentation. News Release. GSK. July 17, 2025. Accessed July 18, 2025. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-gsk-s-shingrix-in-a-prefilled-syringe-presentation/

2. Shingrix approved in the US for prevention of shingles in adults aged 50 and over. News Release. GSK. October 23, 2017. Accessed July 18, 2025. https://www.gsk.com/en-gb/media/press-releases/shingrix-approved-in-the-us-for-prevention-of-shingles-in-adults-aged-50-and-over/

3. Shingrix approved in the US for prevention of shingles in immunocompromised adults. News Release. July 26, 2021. Accessed July 18, 2025. https://www.gsk.com/en-gb/media/press-releases/shingrix-approved-in-the-us-for-prevention-of-shingles-in-immunocompromised-adults/

4. Shingles Facts and Stats. Report. CDC. April 12, 2024. Accessed July 18, 2025. https://www.cdc.gov/shingles/data-research/index.html