GSK Shingrix approved by USFDA in prefilled syringe presentation
London: GSK plc has received approval from the US Food and Drug Administration (FDA) for a prefilled syringe presentation of Shingrix (GSK's Recombinant Zoster Vaccine or RZV) 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 existing vaccine presentation consists of two vials, a lyophilised (powder) antigen and a liquid adjuvant, which healthcare professionals combine prior to administering. The approval of the new presentation is based on data demonstrating technical comparability between the new and existing vaccine presentation.
Brigid Groves, Vice President of Professional Affairs, American Pharmacists Association, said, “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.”
Consistent with the existing indications for Shingrix, the prefilled syringe presentation is licenced 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 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 US 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.
Shingles is a painful, blistering rash that can last for weeks. Approximately 99% of US adults over 50 years old have the virus that causes shingles inside their body, although not everyone will develop shingles. An estimated one million people develop shingles annually in the US.
Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox. By age 50, VZV is present in most adults and may reactivate with advancing age. As people age, the strength of the immune system response to infection wanes, increasing the risk of developing shingles.
