Saturday, January 21, 2023
GSK plc has today announced the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) authorised Sanofi’s SARS-CoV-2 spike protein (B.1.351 strain) vaccine for the prevention of COVID-19 disease in adults aged 18 and above in Great Britain, following the European Commission licence last month, which included Northern Ireland. This SARS-CoV-2 spike protein (B.1.351 strain) vaccine is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received a mRNA or adenoviral COVID-19 vaccine, and the use of this vaccine should be in accordance with official recommendations1.
The approval is based on results from two separate immunogenicity trials, including one comparative trial with an approved mRNA booster as a comparator1,2,3. 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”.