FDA Reviews GSK’s Prefilled Syringe For Shingrix Vaccine

GSK plc has announced that the US Food and Drug Administration (FDA) has accepted its application for a new prefilled syringe version of Shingrix, the company’s recombinant zoster vaccine for preventing shingles (herpes zoster). This new prefilled syringe presentation reduces vaccination complexity because healthcare providers no longer have to work with different vials to prepare the vaccine.

The current version has a method that involves the reconstitution of a powdered antigen and a liquid adjuvant, while the new option has a similar but ready-to-use formulation. The FDA submission includes data that proves that the new formulation is interchangeable with the reconstituted vaccine.  Shingrix has been approved in the US since 2017 for adults aged 50 and older to prevent shingles. In 2021, its use was expanded to adults 18 and older who are at higher risk due to immunosuppression or specific medical conditions.