GSK application for new Shingrix formulation accepted by FDA

GSK announced on Friday that the US Food and Drug Administration (FDA) has accepted its regulatory application for a prefilled syringe version of Shingrix, its recombinant zoster vaccine for preventing shingles.

The FTSE 100 pharmaceutical giant said that if approved, the new presentation would eliminate the need for reconstituting vials before administration, offering a more convenient option for delivering the vaccine.

It said the prefilled syringe has the same composition as the current two-vial formulation, which requires combining a lyophilized antigen and liquid adjuvant.

GSK’s submission included data demonstrating comparability between the two formats, with the FDA expected to make a decision by 30 June.

Shingrix has been approved in the US since 2017 for adults aged 50 and over to prevent shingles and, since 2021, for adults aged 18 and older at increased risk due to immunodeficiency or immunosuppression.

More than 90 million doses of Shingrix have been distributed in the US since its launch.

Shingles, caused by reactivation of the varicella-zoster or ‘chickenpox’ virus, affects about one million people annually in the US.

GSK said the painful condition is more common in older adults as immune responses weaken with age.

Shingrix, a non-live recombinant subunit vaccine, was designed to address the challenge by combining an antigen with an adjuvant system to enhance immune response in adults aged 50 and above.

At 0849 GMT, shares in GSK were up 0.32% at 1,358.8p.

Reporting by Josh White for Sharecast.com.