Sanofi-GSK Adjuvanted Bivalent (D614 and B.1.351) COVID-19 Vaccine Demonstrates High Efficacy Against Omicron Variant

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News on June 24, 2022 /BioValleyBIOON/ -- GSK and Sanofi recently announced positive data from the clinical trial of their adjuvanted bivalent D614 and β (B.1.351) candidate vaccine. Notably,This vaccine is the first COVID-19 vaccine proven effective in a placebo-controlled trial conducted in an environment with a high prevalence of the Omicron variant.In the trial, this adjuvant bivalent vaccine showed good safety and tolerability.

In the phase 3 trial involving more than 13,000 participants aged 18 and aboveCOVID-19Phase 2 of the VAT08 vaccine trial,In the general population, this adjuvanted bivalent vaccine is used for primaryImmunity（primary vaccination），PreventionThe efficacy against symptomatic COVID-19 was 64.7% (95% CI: 46.6, 77.2]), and the efficacy against symptomatic Omicron COVID-19 was 72% (95% CI: 45.8, 86.6]).

In addition, according to the sequence analysis conducted so far,In previously seropositive (previouslyInfectionIn individuals who have previously been infected with COVID-19, the adjuvanted bivalent vaccine demonstrated 75.1% efficacy (95% CI: 56.3, 86.6]) in preventing symptomatic infections and93.2%（95%CI:73.2，99.2）。In Phase 1 and Phase 2 of the VAT08 trial (with a total of approximately 23,000 participants), this adjuvanted bivalent vaccine demonstrated good safety and tolerability.

Currently, Sanofi and GSK are collaborating on developmentThe next-generation COVID-19 booster vaccine, which is modeled on the Beta variant antigen and combined with GSK's pandemic adjuvant.In this collaboration, Sanofi provides recombinant antigens, and GSK provides pandemic adjuvants.This next-generation COVID-19 booster vaccine is designed to specifically target the Beta variant, but it also provides protection against multiple variants, including Omicron BA.1 and BA.2.

Earlier this month, Sanofi reported positive data from two clinical trials (VAT02 Cohort 2, COVIBOOST VAT013) for this next-generation COVID-19 booster vaccine. The results showed,In adults who have received the primary mRNA vaccine series, the next-generation COVID-19 booster vaccine triggered a significant immune boost, with a higher immune response compared to Pfizer's Comirnaty booster.In addition,This next-generation COVID-19 booster vaccine also shows protective potential against a broad range of viral variants, including Omicron BA.1 and BA.2.These compelling data support the submission of this next-generation booster vaccine for regulatory approval and indicate that the Sanofi-GSK next-generation booster vaccine, based on the β variant, has the potential to be a relevant response to public health needs.

GSK Vaccine President Roger Connor said, "These positive data demonstrate the efficacy of our protein-based bivalent adjuvanted candidate vaccine in a context of high Omicron variant prevalence. As the pandemic continues to evolve, our candidate vaccine has the potential to make a significant contribution to public health. We look forward to discussions with regulators to make our candidate vaccine available later this year."

Sanofi Vaccines Executive Vice President Thomas Triomphe stated, "The results today reinforce the strong potential of the β antigen to provide broad protection against multiple viral variants. The immunogenicity data from our β booster vaccine supports the notion that, in a seropositive (previously infected with COVID-19) world, a new generation of β booster vaccines can offer protection against variants such as Omicron. mRNA vaccines have demonstrated rapid market entry; here, we showcase the efficacy that our recombinant protein platform can deliver to the world. We look forward to completing our submissions to regulatory authorities and preparing to contribute to ongoing vaccination programs with our next-generation booster vaccine." (Bioon.com)

Source of Original Text:Sanofi-GSK first to report a successful efficacy study against Omicron with COVID-19 Beta-containing vaccine