The US Food and Drug Administration (FDA) has approved GSK’s Shingrix in a prefilled syringe presentation, simplifying the administration process for healthcare professionals.
The new format of Shingrix, the recombinant zoster vaccine (RZV), eliminates the need for making separate vials, streamlining the prevention of shingles (herpes zoster) in adults.
Shingles, a painful and blistering rash, is caused by the reactivation of the varicella-zoster virus (VZV), which remains dormant in most adults by age 50.
Shingrix is a non-live recombinant subunit vaccine, designed for adults aged 50 and above.
The vaccine combines glycoprotein E with an adjuvant system, AS01B, to address the age-related decline in immune response.
It is not indicated for primary varicella infection (chickenpox) but is approved in several countries for adults aged 18 and over at increased risk for shingles.
Previously, the vaccine required two separate vials, a lyophilised antigen and a liquid adjuvant, to be mixed before administration.
The approval for the prefilled syringe is based on data showing technical comparability with the existing presentation.
In the US, the prefilled syringe is licensed for adults aged 50 and older, and those 18 and older at increased risk due to immunodeficiency or immunosuppression.
The US Centres for Disease Control and Prevention (CDC) recommends two doses for these groups to prevent shingles and related complications.
The European Medicines Agency (EMA) is currently reviewing the prefilled syringe presentation, with filing acceptance received in January 2025.
GSK is also considering submissions in other markets, demonstrating its commitment to enhancing adult immunisation rates.
GSK chief scientific officer Tony Wood said: “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 1 in 3 US adults will develop in their lifetime.”
