GSK plc has announced that the US Food and Drug Administration (FDA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster).
· If approved, the new presentation will offer a convenient administration option to healthcare professionals
· Over 90 million doses of GSK’s shingles vaccine have been distributed in the US since 2017[1]
· An FDA decision on the application is expected by 20 June 2025
The new prefilled syringe removes the need to reconstitute separate vials prior to administration, offering a convenient option for pharmacists, physicians and other healthcare professionals who administer vaccinations. The current presentation of the vaccine consists of a lyophilised (powder) antigen and a liquid adjuvant, which healthcare professionals combine prior to administering. The new presentation has the same composition as the reconstituted vaccine and the submission is based on data demonstrating comparability between the two. 1
Today’s announcement marks an important regulatory milestone for GSK’s shingles vaccine, which has been approved in the US for the prevention of shingles in adults aged 50 years and older since 2017; and in adults 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, since 2021. [2] It reflects GSK’s continued innovation on its commercialised portfolio to meet the needs of the healthcare community.
[1]. GSK data on file 2024.
[2]. Shingrix prescribing information. SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted), suspension for intramuscular injection. Last accessed: January 2025.
