Business
Sanofi-GSK COVID booster vaccine approved by EU
Sanofi-GSK COVID booster vaccine approved by EU.
About this update from Gsk Plc
[{"type":"text","content":"\n \n \n Issued: 10 November 2022, London UK\n \n \n \n \n \n \n \n \n Sanofi and GSK's next-generation COVID-19 booster vaccine VidPrevtynBeta approved by the European Commission\n \n \n \n \n \n \n ·\n First and only next-generation protein-based adjuvanted COVID-19 booster approved in Europe\n \n \n ·\n Strong immune response against all tested variants of concern\n \n \n ·\n Ready to supply for autumn and winter COVID-19 vaccination campaigns in Europe\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n After the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn Beta, the vaccine has been approved by the European Commission as a booster for the prevention of COVID-19 in adults 18 years of age and older.\n Next-generation COVID-19 vaccines are based on a variant-adapted approach, using a strain other than the parental strain of SARS-CoV-2 (D614 strain).\n The vaccine is based on the Beta variant antigen and includes GSK's pandemic adjuvant. The vaccine is indicated as a booster for active immunisation against SARS-CoV-2 in adults who have previously received a mRNA or adenoviral COVID-19 vaccine. Shipments of the vaccine are ready to be distributed to European countries as per the Advance Purchase Agreements.\n \n \n \n \n \n \n Thomas Triomphe, Executive Vice President, Sanofi Vaccines:\n \n \"Today's approval validates our research in developing a novel solution for the COVID-19 pandemic. As we're ready to start first shipments, VidPrevtyn Beta will be an important new option to protect populations against multiple strains of COVID-19.\"\n \n \n \n \n \n \n Phil Dormitzer\n \n \n ,\n \n \n Global Head of Vaccines R&D, GSK\n \n \n :\n \n \"The approval from the European Commission is an important step in providing further vaccine solutions to Europe for the coming autumn and winter. Our protein-based, adjuvanted vaccine has the potential to make an important contribution to public health as the pandemic evolves further.\" \n \n \n \n \n \n In registrational trials, carried out at times when the Omicron variant was predominantly circulating, the vaccine induced a strong immune response against multiple variants. Registration trials included a Phase III primary efficacy trial (VAT08 Sta...