The U.S. Food and Drug Administration (FDA) has approved a prefilled syringe presentation of GSK plc’s SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster).

The new prefilled syringe removes the need to reconstitute separate vials prior to administration, simplifying the vaccine administration process for healthcare professionals. The approval of the new presentation is based on data demonstrating technical comparability between the new and existing vaccine presentation.

Consistent with the existing indications for SHINGRIX, the prefilled syringe presentation is licensed in the U.S. 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 due to immunodeficiency or immunosuppression caused by known disease or therapy. The U.S. Centers for Disease Control and Prevention (CDC) recommends two doses of GSK’s shingles vaccine to prevent shingles and related complications in adults aged 50 years or over, and two doses for adults aged 19 years or over who are or will be immunodeficient or immunosuppressed.

Tony Wood, Chief Scientific Officer, GSK, said: “At GSK, we are committed to advancing scientific innovation and delivering practical solutions that address the needs of the healthcare community. 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 U.S. adults will develop in their lifetime.”

The prefilled syringe presentation of GSK’s shingles vaccine is also undergoing regulatory review by the European Medicines Agency (EMA), with filing acceptance received in January 2025. In addition to GSK exploring submission of this presentation to other markets.