GSK PLC (LSE:GSK, NYSE:GSK) has announced that the US Food and Drug Administration (FDA) is reviewing its new prefilled syringe version of Shingrix, its shingles vaccine.
If approved, the updated delivery method would simplify vaccine administration by eliminating the need to mix separate components before use. An FDA decision is expected by 20 June 2025.
The prefilled syringe contains the same composition as the current vaccine, which combines a lyophilised antigen and liquid adjuvant.
This move builds on Shingrix’s success, with over 90 million doses distributed in the US since its launch in 2017.
Shingrix is approved for adults aged 50 and older, and for those 18 and above at heightened risk due to weakened immune systems.
Shingles, caused by reactivation of the varicella-zoster virus, affects about one million Americans annually.
GSK’s recombinant zoster vaccine aims to protect against this painful condition, which becomes more likely as the immune system weakens with age.