PHILADELPHIA, PA — GSK plc recently received approval from the U.S. Food and Drug Administration (FDA) for a prefilled syringe version of SHINGRIX, the company’s vaccine for shingles (herpes zoster). The new format simplifies the vaccination process by eliminating the need to mix separate components prior to administration.
Previously, SHINGRIX required healthcare professionals to reconstitute two separate vials—one containing a powdered antigen and the other a liquid adjuvant. The prefilled syringe streamlines this step, providing a more efficient option for medical staff and potentially reducing administration errors.
The FDA’s decision follows data demonstrating technical comparability between the new presentation and the existing formulation. The prefilled version retains the same safety, efficacy, and immunization schedule currently approved for SHINGRIX.
“This new presentation of Shingrix was developed to streamline the vaccination process, supporting healthcare professionals to provide protection against shingles,” said Tony Wood, Chief Scientific Officer at GSK. He emphasized the company’s commitment to delivering practical healthcare solutions, noting that shingles affects one in three U.S. adults during their lifetime.
Brigid Groves, Vice President of Professional Affairs at the American Pharmacists Association, praised the update as a “positive step toward driving prevention of this painful disease,” adding that the convenience of a prefilled syringe could improve vaccine uptake.
SHINGRIX is indicated for adults aged 50 and older, as well as for those 18 and older who are immunocompromised due to medical conditions or treatments. The Centers for Disease Control and Prevention (CDC) recommends a two-dose series for both populations.
Shingles, caused by reactivation of the varicella-zoster virus, leads to painful rashes and can result in long-term complications such as postherpetic neuralgia. The CDC estimates that around one million Americans develop shingles each year.
The new prefilled syringe presentation is also under review by the European Medicines Agency (EMA), with filing acceptance confirmed earlier this year. GSK is evaluating submissions to additional global markets as part of its effort to broaden access and increase adult vaccination rates worldwide.
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