- Next-generation booster vaccine candidate delivers immune boost in adults primed with mRNA vaccines; with a stronger immune response compared to Pfizer-BioNTech’s Comirnaty booster vaccine
- Next-generation booster vaccine candidate demonstrates potential to protect against COVID-19 variants of concern, including Omicron BA.1 and BA.2, with a favorable safety and tolerability profile
Paris – June 13, 2022 –
In the Phase 3 VAT02 Cohort 2 study, the Sanofi-GSK next-generation 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. The Sanofi-GSK next-generation booster candidate generated double the number of neutralizing antibodies against Omicron BA.1 and BA.2 compared to the D614-based (original parent virus) booster.
In parallel, the independent COVIBOOST (VAT013) study conducted by the Assistance Publique – Hôpitaux de
- 76.1% (95% CI 64.5–85.4) for the Sanofi-GSK next-generation booster, vs
- 63.2% (95% CI 51.3–73.9) for the Pfizer BioNTech D614 booster, and
- 55.3% (95% CI 43.4–66.7) for the Sanofi-GSK D614 (first-generation parent booster candidate).
In this study, which included 247 subjects, all the three vaccines also elicited neutralizing antibodies against the Omicron BA.1 variant, with highest responses generated by the Sanofi-GSK next-generation candidate. Results of COVIBOOST study are available on a pre-print server, pending publication in a peer-reviewed journal.
Across both studies, the Sanofi-GSK next-generation vaccine candidate was well-tolerated, with a favorable safety profile. In the VAT02 cohort 2 study, low numbers (less than 4%) of Grade 3 reactions were reported, all transient and non-severe.
Executive Vice President, Sanofi Vaccines
“COVID-19 keeps evolving and the combination of emergence of variants and waning immunity is likely to lead to the need for additional booster shots, at least in some populations. The Beta variant expresses similar mutations across multiple variants of concern, including Omicron, making it a strong vaccine candidate to confer broad protection against multiple strains of COVID-19. Seeing the cross-neutralization data from the independent AP-HP study, we believe this next-generation booster could have an important role to play for public health vaccination campaigns. We look forward to submitting these data to global regulatory authorities.”
About VAT02
The VAT02 booster study is an extension of the company’s phase 3 safety and immunogenicity study. In Cohort 1 of this study, participants previously vaccinated with the primary series of an authorized COVID-19 vaccine received a booster dose of the Sanofi-GSK adjuvanted recombinant vaccine candidate, using SARS-CoV-2 (D614) antigen. These data confirmed the vaccine candidate’s universal potential to boost neutralizing antibodies 18- to 30-fold across all vaccine platforms (mRNA, protein, adenovirus). Cohort 2 included 1,500 participants. VAT02 results will be published in a peer-reviewed journal at a later date.
These efforts are supported by federal funds from the
About COVIBOOST (VAT013) study
COVIBOOST is an independent study conducted by the Assistance Publique – Hôpitaux de
About the
In the collaboration between the two companies,
About
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
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