• SARS-CoV-2 spike protein (B.1.351 strain) vaccine is the first and only protein-based variant COVID-19 booster vaccine approved in Great Britain and the European Union
• Results show the SARS-CoV-2 spike protein (B.1.351 strain) vaccine demonstrated an immune response against all tested variants of concern¹

The approval is based on results from two separate immunogenicity trials, including one comparative trial with an approved mRNA booster as a comparator^1,2,3. In these registrational immunogenicity trials, carried out at times when the Omicron variant was predominantly circulating, the vaccine induced a neutralising antibody response against all tested variants of concern.^1,2,3 This vaccine is based on the Beta variant spike antigen and includes GSK’s adjuvant. Across the registrational trials, the vaccine candidate was generally well-tolerated, with an acceptable safety profile.¹

This booster vaccine was developed jointly by Sanofi and GSK.

Rebecca Catterick, General Manager, Sanofi Vaccines, UK & Ireland: “Today’s approval validates our research in developing a novel solution for the COVID-19 pandemic. VidPrevtyn Beta will be an important new option to help protect populations against COVID-19.” 

Phil Dormitzer, Global Head of Vaccines R&D, GSK: “The approval from MHRA of our protein-based, adjuvanted vaccine is a vital step for providing further vaccine solutions to Great Britain this winter. Boosters have an important role in protecting people from COVID-19”.