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FDA approves GSK’s prefilled syringe presentation of Shingrix

The US CDC advises that adults aged 50 and older should receive two doses of the shingles vaccine.

samatharenigunta July 18 2025

The US Food and Drug Administration (FDA) has approved GSK's Shingrix vaccine (recombinant zoster vaccine or RZV) in a prefilled syringe presentation to prevent shingles (herpes zoster).

This development will streamline the process for healthcare professionals by eliminating the need to mix components before administration.

Administering Shingrix previously required combining a lyophilised antigen with a liquid adjuvant from two separate vials.

The newly approved prefilled syringes are based on data demonstrating technical comparability between the new and original vaccine presentations.

In line with current indications for Shingrix, the prefilled syringe formulation is approved in the US for the vaccination of adults aged 50 years and older, as well as individuals aged 18 and above at an increased risk of developing shingles due to immunodeficiency or immunosuppression.

The US Centres for Disease Control and Prevention (CDC) advises that adults aged 50 and older should receive two doses of the vaccine to prevent shingles and its complications.

Those aged 19 and older who are immunodeficient or immunosuppressed should also receive two doses.

GSK chief scientific officer Tony Wood stated: “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 protect against shingles, a disease that one in three US adults will develop in their lifetime.”

The European Medicines Agency (EMA) is also reviewing this updated version of GSK's shingles vaccine following acceptance of its filing in January 2025.

GSK's efforts to reintroduce its blood cancer drug Blenrep (belantamab mafodotin) faced a setback when the FDA raised eye safety concerns before a meeting to evaluate the therapy's benefit-risk profile.

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