GSK plc announced the European Commission's (EC) approval of Shingrix (GSK's Recombinant Zoster Vaccine or RZV) in a prefilled syringe. The current vaccine presentation comprises two vials, one with a lyophilised powder antigen and another with a liquid adjuvant. The lyophilised powder antigen requires reconstitution, where the suspension in the adjuvant vial is withdrawn and injected into the antigen vial.
The new prefilled syringe simplifies the vaccine administration process for healthcare professionals by removing the need to undertake these steps prior to administration. This approval is based on data confirming technical comparability between the prefilled syringe and the existing vaccine presentation. The new presentation does not involve a change in indication or dosing.
