GSK has received approval from the US Food and Drug Administration (FDA) for a new prefilled syringe presentation of Shingrix (Recombinant Zoster Vaccine, RZV), designed to prevent shingles (herpes zoster).

The new format eliminates the need to reconstitute separate vials prior to administration, simplifying the vaccine administration process for healthcare professionals.

The existing vaccine presentation consists of two vials, a lyophilised (powder) antigen and a liquid adjuvant, which healthcare professionals combine prior to administering.

The FDA approval is based on data showing technical comparability between the new prefilled syringe and the original two-vial presentation.

Brigid Groves, Vice President of Professional Affairs, American Pharmacists Association, commented: “The prefilled syringe presentation of GSK’s shingles vaccine is good news, providing a convenient method of administration. 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.”

Shingles is a painful, blistering rash that can last for weeks. It is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox. An estimated one million people develop shingles annually in the US.

Consistent with the existing indications for Shingrix, the newly approved prefilled syringe presentation is licensed in the US for immunisation 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 US Centers for Disease Control and Prevention (CDC) recommends two doses of the vaccine for both age groups to prevent shingles and related complications.

Tony Wood, Chief Scientific Officer at GSK, emphasised the significance of the new format, “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.”

Regulatory review of the prefilled syringe presentation is also underway in Europe, with the European Medicines Agency (EMA) having accepted the filing in January 2025. GSK is also exploring the submission of this presentation to other markets to help increase adult immunisation rates.