GSK’s Shingrix approved by the U.S. FDA

GSK recently announced that they have approved a prefilled syringe presentation of Shingrix for the prevention of shingles. The new prefilled syringe removes the need to reconstitute separate vials prior to administration, simplifying the vaccine administration process for healthcare professionals.

Note that the existing vaccine presentation consists of two vials, a lyophilised antigen and a liquid adjuvant, which healthcare professionals combine prior to administering. This approval of the new presentation is based on data demonstrating technical comparability between the new and existing vaccine presentation.

Brigid Groves, Vice President of Professional Affairs, American Pharmacists Association, said: “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.”

The prefilled syringe presentation is licenced in the US for immunisation of adults aged 50 years and older, as well as those aged 18 years and older who are or will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy.

Tony Wood, Chief Scientific Officer, GSK, 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.”

 

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GSK’s Shingrix