Next-Gen Protein-Based Adjuvanted COVID-19 Booster Approved in Europe
After the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for VidPrevtyn® Beta, the European Commission (EC) approved the vaccine on November 10, 2022, as a booster for the prevention of COVID-19 in adults.
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.
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).
In the collaboration between the two companies, Sanofi provides its recombinant antigen and will be the marketing authorization holder.
And GSK contributes with its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza.
Designed to provide broad protection against multiple coronavirus variants, the protein-based COVID-19 booster vaccine is based on the Beta variant antigen and includes GSK's pandemic adjuvant.
Thomas Triomphe, EVP, Vaccines, Sanofi, commented in a related press release, "Today's (EC) 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."
VidPrevtyn Beta is a monovalent, recombinant-protein COVID-19 vaccine developed by Sanofi, modeled on the Beta variant.
The companies announced on June 13, 2022, in the Phase 3 VAT02 Cohort 2 study, the vaccine candidate induced (at day 15 post-immunization) a significant boost in antibody titers above baseline against multiple variants of concern (15-fold increase against D614 parent virus, 30-fold increase against Beta strain) in adults previously primed with mRNA COVID-19 vaccines.
In particular, against Omicron, preliminary data show a 40-fold increase against BA.1.
Shipments of VidPrevtyn Beta to European countries are expected in late 2022.