GSK’s Shingrix new prefilled syringe presentation accepted for review by FDA

GSK (GSK) announced that the US Food and Drug Administration, FDA, has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix for the prevention of shingles. The new prefilled syringe removes the need to reconstitute separate vials prior to administration, offering a convenient option for pharmacists, physicians and other healthcare professionals who administer vaccinations. The current presentation of the vaccine consists of a lyophilised antigen and a liquid adjuvant, which healthcare professionals combine prior to administering. The new presentation has the same composition as the reconstituted vaccine and the submission is based on data demonstrating comparability between the two.