FDA OKs Shingrix Prefilled Syringe: Daily Dose

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On July 17, 2025, we reported on the US FDA approval of a prefilled syringe presentation of Shingrix (recombinant zoster vaccine [RZV]) for the prevention of shingles (herpes zoster).

The approval

The approved prefilled syringe carries identical licensing for immunization 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 as a result of immunodeficiency or immunosuppression caused by disease or therapy. The approval was based on data demonstrating technical comparability between the new prefilled syringe and the existing vaccine presentation, which consists of 2 vials, one containing a lyophilised antigen and the other a liquid adjuvant; the 2 must be combined prior to administering the shot.

Shingrix combines an antigen, glycoprotein E, with an adjuvant system, AS01B, and may help overcome the natural age-related decline in responses to immunization that contributes to the challenge of protecting adults aged 50 years and older.

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