GSK's Shingrix Prefilled Syringe Under Review by FDA and EMA for Shingles Prevention
Key Insights
The FDA and EMA are reviewing GSK's application for a Shingrix prefilled syringe, potentially streamlining vaccine administration.
The new syringe formulation aims to simplify the vaccination process by removing the need for reconstitution.
Shingrix is a recombinant zoster vaccine indicated for the prevention of shingles (search) in adults, with over 90 million doses distributed in the US since 2017.
GSK's Shingrix, a recombinant zoster vaccine (RZV) used for the prevention of shingles (search) (herpes zoster (search)), is under review by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a new prefilled syringe presentation. This new presentation aims to simplify vaccine administration by eliminating the need to reconstitute separate vials prior to injection, offering a more convenient option for healthcare professionals.
Regulatory Milestones
The FDA accepted GSK's application for review on January 8, 2025, with a decision expected by June 20, 2025. Following this, the EMA also accepted the application for review. These regulatory milestones reflect GSK's commitment to improving adult immunization practices. "The new presentation has the same composition as the reconstituted vaccine and the submission is based on data demonstrating comparability between the two," GSK noted.
Shingrix: Addressing Shingles Prevention
Shingrix is a non-live, recombinant subunit vaccine that combines glycoprotein E antigen with the AS01B adjuvant system. It is indicated for the prevention of shingles (search) in adults aged 50 years and older, and since 2021, it has been approved for adults 18 years and older who are at increased risk of shingles due to immunodeficiency or immunosuppression. Shingles is caused by the reactivation of the varicella-zoster virus (search) (VZV), the same virus responsible for chickenpox. Approximately 99% of US adults over 50 years old have VZV present in their bodies, with about one million cases of shingles occurring annually in the US.
Convenience and Impact
The current presentation of Shingrix requires healthcare professionals to combine a lyophilized (powder) antigen with a liquid adjuvant before administering the vaccine. The prefilled syringe formulation seeks to enhance convenience for pharmacists, physicians, and other healthcare providers, potentially increasing vaccination rates. As GSK stated, a prefilled syringe will be more convenient for healthcare workers administering the vaccine.
Clinical Efficacy and Long-Term Protection
Clinical trials have demonstrated that Shingrix has an efficacy of over 90% against shingles (search) across all age groups, with sustained efficacy observed over a follow-up period of up to 11 years. By preventing shingles, Shingrix also reduces the risk of postherpetic neuralgia (PHN), a chronic nerve pain and the most common complication associated with shingles. Since its initial approval in 2017, approximately 90 million doses of Shingrix have been administered in the United States.