Key takeaways:
- The unique formulation of Shingrix consists of two separate vials mixed by well being care staff previous to administration.
- The brand new formulation streamlines this course of.
The FDA has authorised a prefilled syringe possibility of Shingrix which is able to streamline administration of GSK’s herpes zoster vaccine for grownup sufferers.
Shingrix was initially authorised by the FDA in 2017 for the prevention of shingles in adults aged 50 years or older and was later authorised for immunocompromised adults aged 18 years or older in 2021. The newly authorised presentation, which was introduced by the corporate on Thursday, can also be licensed for each of those populations.
The FDA has authorised the simplified prefilled syringe formulation of GSK’s recombinant zoster vaccine for sufferers eligible to obtain the unique formulation together with adults aged 50 years or older and immunocompromised adults aged 18 years or older.
Based on GSK, thes prefilled syringe possibility simplifies the present formulation which consists of two separate vials — a lyophilized antigen and a liquid adjuvant — which is mixed by well being care staff previous to administration.
“This new presentation of Shingrix was developed to streamline the vaccination course of, supporting well being care professionals to supply safety towards shingles, a illness that one in three U.S. adults will develop of their lifetime,” GSK chief scientific officer Tony Wooden mentioned in a press launch.
The approval of the brand new presentation is predicated on information that demonstrated “technical comparability between the brand new and current vaccine presentation,” though GSK didn’t make these information accessible on the time of the FDA announcement.
Based on GSK, the prefilled syringe can also be below evaluate by the European Medicines Company, with submission accepted in January 2025. The corporate mentioned it has plans for added regulatory filings in different markets as a part of its broader immunization technique.
