FDA Reviewing New Prefilled Syringe Formulation for GSK’s Shingrix

An FDA decision on GSK's Shingrix application is expected by June 20, 2025.

The US Food and Drug Administration (FDA) has accepted for review GSK’s regulatory application for a prefilled syringe (PFS) presentation of Shingrix (Recombinant Zoster Vaccine [RZV]) for the prevention of shingles, according to a GSK news release.1

If approved, this new formulation would eliminate the need to reconstitute separate vials prior to administration and offer a potentially more convenient option for health care professionals. The PFS presentation could help streamline vaccination workflows in a variety of practice settings, the company said.

An FDA decision on the application is expected by June 20, 2025.1

Since its approval in 2017, more than 90 million doses of Shingrix have been distributed in the United States. Shingrix currently requires mixing a lyophilized antigen and liquid adjuvant, whereas the new PFS presentation would include a ready-to-use liquid formulation containing both components in a single syringe. The PFS is the same composition as the currently licensed vaccine, GSK said.

Shingrix is indicated for adults aged 50 years and older for the prevention of shingles, and since 2021, it has also been approved for individuals aged 18 years or older who are, or will be, at increased risk of shingles because of immunodeficiency or immunosuppression caused by disease or therapy. Shingrix combines a non-live, recombinant glycoprotein E antigen with the AS01B adjuvant system, aiming to overcome the age-related decline in immune response that contributes to the risk of developing shingles.

Shingles is caused by the reactivation of latent varicella-zoster virus (VZV), the same virus responsible for chickenpox. By age 50, most adults have VZV present in their bodies, and immunosenescence — age-associated decline of the immune system—may facilitate viral reactivation. Approximately 99% of US adults over 50 years old have the virus that causes shingles inside their body, although not every patient will develop shingles. Each year, about 1 million people in the United States develop shingles.

Reference

  1. GSK’s Shingrix new prefilled syringe presentation accepted for review by US FDA [press release]. Published January 11, 2025. Accessed January 13, 2025.
    https://www.gsk.com/en-gb/media/press-releases/gsk-s-shingrix-new-prefilled-syringe-presentation-accepted-for-review-by-us-fda/