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GSK wins US approval for prefilled syringe version of shingles vaccine

ALN

GSK PLC on Thursday said the prefilled syringe version of its vaccine Shingrix has been approved for use in the US for the prevention of shingles.

The London-based drug maker said the US Food & Drug Administration approved the prefilled syringe version, which ‘removes the need to reconstitute separate vials prior to administration’.

This simplifies the vaccination process for healthcare professionals, GSK added.

The existing vaccine is made up of two vials which are combined prior to administering. The approval is based on data which demonstrated the technical comparability between the new and existing presentation.

The prefilled syringe presentation is licensed in the US for the immunisation of adults aged 50 or older, as well as those aged 18 and older who are at increased risk of shingles due to immunodeficiency or immunosuppression.

‘At GSK, we are committed to advancing scientific innovation and delivering practical solutions that address the needs of the healthcare community,’ said Chief Scientific Officer Tony Wood.

‘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.’

The prefilled syringe version is also undergoing regulatory review by the European Medicines Agency.

Shares in GSK were down 0.5% at 1,415.00 pence in London on Thursday morning.

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