GSK Gains EU Approval for Shingrix Prefilled Syringe Version

GSK has obtained a new prefilled syringe variant of Shingrix, which is an update to one of the most popular brands of shingles vaccines globally.

The ruling paves the way to an improved presentation that will save time on preparation and facilitate the delivery of vaccines in the healthcare environment of Europe.

The new format is an alternative to the current two-vial system, where healthcare professionals used to combine a lyophilized antigen and a liquid adjuvant and inject. Using the GSK Shingrix prefilled syringe, the step is omitted and the vaccine can be delivered directly. According to GSK, the change is directed at the workflow efficiency, but the clinical profile remains the same.

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“This new presentation of Shingrix has been designed to improve ease of administration, helping healthcare professionals to provide protection against shingles,” said Tony Wood, Chief Scientific Officer, GSK. 

“Shingles is a painful disease that can have serious and long-lasting complications. It affects millions of people each year in Europe, often imposing a greater burden on people living with common chronic diseases such as cardiovascular disease and diabetes. GSK is proud to support the healthcare community by making administration of its shingles vaccine easier."

Data indicated that the prefilled syringe is technically equivalent to the existing system of two-vials to gain approval by the European Commission. GSK assured that the update does not alter the approved indication, dose and clinical use of Shingrix.