Shingrix Prefilled Syringe Gets FDA Greenlight, According to GSK

The FDA has approved a prefilled syringe presentation of Shingrix (recombinant zoster vaccine [RZV]) for the prevention of shingles (herpes zoster), eliminating the need for health care professionals to reconstitute separate vials prior to administration. The new presentation simplifies the vaccine administration process but does not change the clinical indications for the existing 2-vial formulation, according to the July 17 GSK announcement.1

Varicella zoster

The approved prefilled syringe carries identical licensing for immunization of adults aged 50 years and older, as well as those aged 18 years and older who are or will be at increased risk of shingles as a result of immunodeficiency or immunosuppression caused by disease or therapy, the company said.2 The US CDC recommends 2 doses of GSK's RZV to prevent shingles and related complications in the 2 key populations.3

"The prefilled syringe presentation of GSK's shingles vaccine is good news, providing a convenient method of administration," Brigid Groves, vice president of professional affairs, American Pharmacists Association, said in a statement. "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."1

GSK based the approval on data demonstrating technical comparability between the new prefilled syringe and the existing vaccine presentation, which consists of 2 vials, one containing a lyophilised antigen and the other a liquid adjuvant; the 2 must be combined prior to administering the shot. The company has not released specific efficacy or safety data comparing the 2 presentations.1

Shingles affects approximately 99% of US adults over 50 years old who have the varicella-zoster virus dormant in their bodies, though not everyone will develop the condition, according to the statement.4 The disease manifests as a painful, blistering rash that can persist for 2 weeks; the CDC estimates the eruption manifests in approximately 1 million US adults annually.4

"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," Tony Wood, GSK chief scientific officer, said in the statement.1

Shingrix combines an antigen, glycoprotein E, with an adjuvant system, AS01B, and may help overcome the natural age-related decline in responses to immunization that contributes to the challenge of protecting adults aged 50 years and older The vaccine is not indicated to prevent primary varicella infection (chickenpox).

The prefilled syringe presentation is currently undergoing regulatory review by the European Medicines Agency, with filing acceptance received in January 2025. GSK has indicated it is exploring submission of this presentation to other markets as part of its commitment to providing solutions that increase adult immunization rates.

References

1. US FDA approves GSK’s Shingrix in a prefilled syringe presentation. News release. GSK. July 17, 2025. Accessed July 17, 2025. https://www.gsk.com/media/n5cjujoe/sea-pr-shingrix-fully-liquid-fda-approval_final.pdf

2. Shingrix. Prescribing information. GSK. 2025. Accessed July 17, 2025. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Shingrix/pdf/SHINGRIX.PDF

3. Shingles vaccine recommendations. Centers for Disease Control and Prevention. Updated October 22, 2014. Accessed July 17, 2025. https://www.cdc.gov/shingles/hcp/vaccine-considerations/index.html

4. About shingles (herpes zoster). Centers for Disease Control and Prevention. Updated January 17, 2025. Accessed July 17, 2025. https://www.cdc.gov/shingles/about/index.html