First and only next-generation protein-based adjuvanted COVID-19 booster vaccine approved in Europe.
After the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive view for VidPrevtyn® Beta, the vaccine was approved by the European Commission, as a booster for the prevention of COVID-19 in adults 18 years of age and older. Designed to provide broad protection against multiple variants, the protein-based COVID-19 booster vaccine is based on the Beta variant antigen and includes GSK’s pandemic adjuvant. VidPrevtyn Beta is aimed as a booster for active immunization against SARS_CoV_2 in adults who have previously received an mRNA or adenoviral COVID vaccine. Shipments of VidPrevtyn Beta are set to be distributed to European countries as per Advance Purchase Agreements.
Thomas Triomphe
Executive Vice President, Vaccines, Sanofi
“Today’s approval validates our research in developing a novel ease for the COVID-19 pandemic. As we’re ready to start first shipments, VidPrevtyn Beta will be an vital new option to protect populations against multiple strains of COVID-19.”
Philip Dormitzer
Global Head of Research and Development Vaccines, GSK
“This EC YES is an important step in providing further vaccine solutions to Europe for the coming winter. Our protein-based, adjuvanted vaccine candidate has the potential to make an important contribution to public health as the pandemic evolves further.”
In registration studies, carried out at times when Omicron strains were predominantly circulating, the vaccine induced a special immune response against multiple variants. Registration studies included a Phase 3 primary efficacy trial (VAT08 Stage 2) and two separate immunogenicity studies, including one comparative study with approved mRNA booster as comparatori,ii.