The French and British drugmakers Sanofi and GSK are ready to seek approval from regulators for their Covid-19 vaccine after reporting positive results from after reporting positive results from late-stage clinical trials.
Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus).
In the VAT08 Phase 3 primary series trial, two doses of the Sanofi-GSK vaccine in seronegative populations demonstrated an efficacy of 57.9% (95% confidence interval CI, 26.5, 76.7) against any symptomatic COVID-19 disease in the seronegative population. The Sanofi-GSK vaccine provided 100% protection (0 vs 10 cases post-dose 1, 0 vs 4 cases post-dose 2) against severe disease and hospitalizations and 75% (3 vs 11 cases) efficacy against moderate-to-severe disease in seronegative populations. While sequencing is still in progress, early data indicate 77% efficacy against any Delta variant-associated symptomatic COVID-19 disease, in line with expected vaccine effectiveness.
Across both studies, the Sanofi-GSK vaccine was well-tolerated in younger and older adults with no safety concern.
When used as a two-dose primary series, the Sanofi-GSK vaccine delivered robust levels of neutralizing antibodies, with GMTs reaching 3711 units. For comparison, a panel of sera from volunteers in the same age range who received two doses of an already approved and highly effective mRNA vaccine displayed a GMT of 1653 units, measured simultaneously in the same laboratory.
The public health relevance of the refrigerator temperature-stable adjuvanted protein-based Sanofi-GSK vaccine is strongly supported by the induction of robust immune responses and a favorable safety profile in multiple settings. In participants who had received a primary series of an already authorized mRNA or adenovirus vaccine, the Sanofi-GSK booster vaccine induced a significant increase in neutralizing antibodies of 18- to 30-fold across vaccine platforms and age groups. When the Sanofi-GSK vaccine was used as a two-dose primary series followed by a booster dose, neutralizing antibodies increased 84- to 153-fold compared to pre-boost levels (see Figures 1a and 1b for details).
The companies are in discussions with regulatory authorities, including the US FDA and European Medicines Agency (EMA), and plan to submit the totality of the data generated with this vaccine candidate to support regulatory authorizations.