European Commission approves VidPrevtyn Beta as a booster to prevent COVID 19
After the EMA Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn Beta from GSK and Sanofi, 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. 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)
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 Advance Purchase Agreements.
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 Stage 2) and two separate immunogenicity trials, including one comparative trial with an approved mRNA booster as a comparator.
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