FDA has approved a prefilled syringe version of GSK’s Shingrix, a recombinant zoster vaccine used to prevent shingles, eliminating the need for reconstitution of separate vials prior to administration (1). The newly approved format aims to ease preparation for healthcare professionals, enhancing efficiency and reducing the risk for handling errors during vaccination.
The previous formulation of the shingles vaccine required clinicians to combine a lyophilized antigen with a liquid adjuvant prior to administration (1). FDA’s approval of the new single-syringe version follows data confirming its technical comparability with the original two-vial presentation.
·FDA approval of the prefilled syringe version of the recombinant zoster vaccine supports manufacturing shifts toward ready-to-use, single-dose formats.
·Technical comparability data enabled regulatory clearance without reformulation, highlighting the value of platform consistency in vaccine development.
·Prefilled syringe design may enhance uptake by reducing administration errors and simplifying logistics across healthcare and immunization programs.
Brigid Groves, vice president of professional affairs at the American Pharmacists Association, emphasized the practical benefits of this update (1): “The prefilled syringe presentation of GSK’s shingles vaccine is good news, providing a convenient method of administration. The FDA approval is a positive step toward driving prevention of this painful disease, and as a practicing pharmacist I welcome the availability of this new presentation.”
As with the original version, the prefilled syringe formulation is licensed in the United States for immunization of adults aged 50 and older, as well as individuals aged 18 and older who are or will be immunocompromised due to disease or medical treatment (1). Current guidance from the Centers for Disease Control and Prevention recommends a two-dose series of the vaccine for these groups to help prevent shingles and its complications.
Tony Wood, chief scientific officer at GSK, commented on the public health rationale for the updated presentation, stating “at GSK, we are committed to advancing scientific innovation and delivering practical solutions that address the needs of the healthcare community. This new presentation of Shingrix was developed to streamline the vaccination process, supporting healthcare professionals to provide protection against shingles, a disease that one in three US adults will develop in their lifetime” (1).
In parallel to the US approval, the prefilled syringe presentation is under review by the European Medicines Agency, with the application accepted for evaluation in January 2025 (1). Regulatory submissions are also being considered for additional international markets.
These developments reflect a broader industry focus on increasing adult immunization rates through simplified vaccine formats.
Shingles, also known as herpes zoster, is a painful skin rash caused by reactivation of the varicella-zoster virus (VZV)—the same virus responsible for chickenpox (2). While not all individuals with latent VZV will develop shingles, nearly 99% of US adults over 50 harbor the virus, and about one million cases are diagnosed annually in the US (3).
With age, immune function diminishes, increasing the likelihood that the virus will reactivate (4). This makes older adults more susceptible to shingles and its associated complications, including postherpetic neuralgia, a condition characterized by long-lasting nerve pain.
The recombinant zoster vaccine is a non-live, subunit formulation that combines glycoprotein E with the proprietary AS01B adjuvant system (1). It is designed to trigger a strong immune response even in older adults, whose immune systems may respond less robustly to vaccination. The vaccine is not intended to prevent chickenpox or primary varicella infection.
The newly approved Shingrix format comes just days after GSK announced that FDA had accepted GSK’s application to extend the indication for the company’s respiratory syncytial virus (RSV) vaccine, adjuvanted (Arexvy) to adults aged 18–49 who are at increased risk (5). The vaccine is approved in the US to prevent lower respiratory tract disease (LRTD) caused by RSV in adults older than 60 years. It is also approved to treat people aged 50–59 who have increased risk for LRTD caused by RSV.
1. GSK.
2. Harpaz, R.; Ortega-Sanchez, I.; Seward, J.; et al.
3. CDC.
4. Mueller, N.; et al.
5. Haigney, S.
