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Shingrix new prefilled syringe presentation accepted for review by US FDA – GSK

Written by | 17 Jan 2025 | Immunology

GSK plc  announced that the 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). 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.

The 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.

An FDA decision on the application is expected by 20 June 2025.

Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) is a non-live, recombinant subunit vaccine indicated for the prevention of shingles in adults 50 and over. It combines an antigen, glycoprotein E, with an adjuvant system, AS01B, and may help overcome the natural age-related decline in responses to immunisation that contributes to the challenge of protecting adults aged 50 and over from shingles. RZV is not indicated to prevent primary varicella infection (chickenpox). In several countries, RZV is also approved for adults aged 18 years or over at increased risk for shingles.

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