Sanofi and GSK’s Covid booster vaccine has been approved in Europe.
After the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion 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 indicated 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 ready to be distributed to European countries as per advance purchase agreements.
Thomas Triomphe, executive vice president, vaccines, at Sanofi, said: “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.”
Philip Dormitzer, global head of research and development vaccines, GSK, said: “This EC approval 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 strong immune response against multiple variants. Registration studies included a phase 3 primary efficacy trial and two separate immunogenicity studies, including one comparative study with approved mRNA booster as comparator.
VidPrevtyn Beta is a monovalent, recombinant-protein next-generation Covid-19 vaccine developed by Sanofi, modeled on the Beta variant and including GSK’s pandemic adjuvant.
The same recombinant-protein technology is used in Sanofi’s approved seasonal flu vaccines. 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).
Sanofi and GSK partnership
In the collaboration between the two companies, Sanofi provides its recombinant antigen and will be the marketing authorization holder. GSK contributes with its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza.