The U.S. Food and Drug Administration approval of a prefilled syringe for Shingrix streamlines administration by removing the need to mix two vials.

The FDA approved a prefilled syringe presentation of recombinant zoster vaccine (Shingrix, GSK) for the prevention of herpes zoster. The new presentation eliminates the need to reconstitute two separate vials—lyophilized antigen and liquid adjuvant—prior to administration, offering a streamlined process for healthcare professionals. Regulatory approval was based on data demonstrating technical comparability between the prefilled syringe and existing formulation.

Shingrix remains indicated for adults aged 50 years or older and for those aged 18 years or older who are or will be immunodeficient or immunosuppressed due to underlying disease or therapy. The Centers for Disease Control and Prevention recommends a 2-dose series for both populations. Herpes zoster affects approximately one million patients annually in the U.S. The risk increases with age due to waning cell-mediated immunity, and more than 99% of adults over age 50 harbor latent varicella-zoster virus.

The vaccine is designed to enhance immunogenicity in older adults and is not indicated for prevention of primary varicella infection.

The prefilled syringe presentation is also under review by the European Medicines Agency, with submission accepted in January 2025. GSK plans additional regulatory filings in other markets as part of its broader immunization strategy.

Source: GSK