Sanofi and GSK announced that European Commission (EC) has approved the use of their VidPrevtyn Beta vaccine as a booster in adults, aged 18 years and above.
VidPrevtyn Beta is a monovalent, recombinant-protein, next-generation Covid-19 vaccine developed by Sanofi, leveraging GSK’s pandemic adjuvant.
Designed based on a variant-adapted approach, the next-generation Covid-19 vaccine is modelled based on the Beta variant of SARS-CoV-2.
The EC approval follows a positive recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
VidPrevtyn Beta is indicated as a booster for active immunisation in adults who previously received a mRNA or adenoviral Covid-19 vaccine.
Sanofi Vaccines executive vice president Thomas Triomphe 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.”
The vaccine induced a strong immune response against multiple variants, in Phase 3 VAT08 Stage 2 trial, and two separate immunogenicity trials.
The immunogenicity trials include VAT02 Cohort 2 and COVIBOOST (VAT013) trials.
The Phase 3 VAT08 Stage 2 trial evaluated the efficacy of primary vaccination with a bivalent Covid-19 vaccine containing both parental (D614) and Beta strains.
In the study, the vaccine showed a 64.7% efficacy against symptomatic SARS-CoV-2 infection in adults and 75.1% efficacy in participants previously infected with SARS-CoV-2.
The Phase 3 VAT02 Cohort 2 trial evaluated the vaccine in adults aged 18 to 55 years, who were previously primed with mRNA Covid-19 vaccines.
The vaccine induced a significant rise in pseudo-neutralising titres above baseline against multiple variants of concern, with mostly mild, transient, and self-resolutive reactions.
In the COVIBOOST (VAT013) trial, VidPrevtyn Beta generated a higher immune response compared to Pfizer-BioNTech’s booster or the Sanofi-GSK first-generation booster.
In all the three clinical trials, the vaccine was well-tolerated, with an acceptable safety profile.
Furthermore, the Biomedical Advanced Research and Development Authority (BARDA) has offered US federal funding to support the research and development of the vaccine.
GSK Vaccines R&D global head Phil Dormitzer said: “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.”
