The European Commission has approved the VidPrevtyn Beta COVID-19 vaccine as a booster for individuals who are at least 18.
The vaccine is the first next-gen protein-based adjuvanted COVID-19 booster to win European approval.
After announcing the news, Sanofi shares were up 1.45% to $43.97 in early afternoon trading. GSK shares were up 2.42% to $33.21.
VidPrevtyn Beta is a monovalent, recombinant-protein vaccine developed by Sanofi, modeled on the Beta variant and including GSK’s pandemic adjuvant. The vaccine uses recombinant-protein technology found in Sanofi’s seasonal flu vaccines.
In July, GSK and Sanofi announced that their adjuvanted bivalent version of its vaccine was 72% efficacious against omicron in adults in a Phase 3 study.
GSK and Sanofi noted that the vaccine performed well in registrational trials when the omicron variant was predominant, including a Phase 3 primary efficacy study and two separate immunogenicity trials.
Sanofi tested VidPrevtyn Beta in two immunobridging trials to measure the immune response from the new vaccine relative to a previously approved vaccine.
In the COVIBOOST VAT013 study, the vaccine was administered to participants who had received two prior doses of Pfizer-BioNTech’s Comirnaty vaccine (BNT162b2).
In that study, VidPrevtyn Beta was also pitted against BNT162b2 as a booster. VidPrevtyn Beta offered a superior performance against the omicron BA.1 variant one month after administration. VidPrevtyn Beta led to approximately 2.5 times more neutralizing antibodies against the BA.1 variant and in an exploratory analysis involving the BA.4/BA.5 sublineages of omicron.
VidPrevtyn Beta offers protection against multiple strains of COVID-19, according to Thomas Triomphe, executive vice president of Sanofi Vaccines.
“The approval from the European Commission is an important step in providing further vaccine solutions to Europe for the coming autumn and winter,” said Phil Dormitzer, global head of vaccines R&D, GSK, in a news release.
The U.S. government contributed to the development of the vaccine through federal funds from Biomedical Advanced Research and Development Authority (BARDA).
In 2021, Sanofi announced that it halted the development of an mRNA-based COVID-19 vaccine.
Filed Under: clinical trials, Infectious Disease