BRIEF—Prefilled syringe presentation of Shingrix accepted for review by FDA

The US Food and Drug Administration (FDA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix, GSK’s (LSE: GSK) recombinant zoster vaccine for the prevention of shingles (herpes zoster).

This new prefilled syringe removes the need to reconstitute separate vials prior to administration, offering a convenient option for healthcare professionals. 

The current presentation of the vaccine consists of a lyophilized antigen and a liquid adjuvant, which healthcare professionals combine prior to administering. 

GSK’s new presentation has the same composition as the reconstituted vaccine, and its filing is based on data demonstrating comparability between the two.

More than 90 million doses of GSK’s shingles vaccine have been distributed in the USA since 2017.