FDA Approves Simplified Prefilled Syringe Format for Shingles Vaccine

The U.S. Food and Drug Administration (FDA) has approved a new, more convenient presentation of the shingles vaccine, Shingrix, by GSK. The innovative prefilled syringe format aims to streamline the vaccination process, making it easier for healthcare providers to administer the vaccine. Traditionally, Shingrix comes in two separate vials — one containing the lyophilized (powder) antigen and the other with the liquid adjuvant — which healthcare professionals must manually combine before administration. The prefilled syringe simplifies this step, reducing preparation time and potential for error.

This new presentation aligns with existing indications for the vaccine, approved for adults aged 50 years and older, as well as for individuals aged 18 and above who harbor increased risk of shingles due to immunodeficiency or immunosuppressive therapy. The FDA’s approval was based on data demonstrating that the prefilled syringe offers a comparable safety and efficacy profile to the traditional vial method.

According to Tony Wood, GSK's Chief Scientific Officer, the development of this new vaccine presentation supports healthcare professionals by facilitating faster and easier vaccination, which could increase vaccine uptake and protection against shingles. Shingles, caused by reactivation of the varicella-zoster virus, affects about one in three U.S. adults during their lifetime.

For more detailed information, visit GSK’s official announcement: More Information. This development represents an important step forward in vaccine delivery, particularly for adults at risk of shingles.