In the Phase 3 VAT08 study of the vaccine used for the primary two-dose immunization course of the Sanofi-GSK vaccine in seronegative populations they demonstrated: 100 percent efficacy against severe disease and COVID-19 hospitalizations; 75 percent efficacy against moderate to severe COVID-19 disease; 57.9 percent efficacy against any symptomatic COVID-19 disease, in line with the expected efficacy of the vaccine in the current pandemic situation dominated by variants of concern. The safety profile was favorable for both the primary cycle vaccine and the vaccine as a dose booster. Because of this, Sanofi and GSK announced today that they intend to submit vaccine study data as a dose booster and phase 3 efficacy data in order to initiate authorization applications for their COVID-19 vaccine. The adjuvanted protein Sanofi-GSK vaccine (which must be kept at refrigerator temperature), in addition to having a significant impact on health, has shown robust immune responses and a favorable safety profile in multiple contexts. In participants who had received primary immunization with mRNA vaccine or with already licensed adenovirus vaccine, the Sanofi-GSK booster vaccine induced a significant increase in neutralizing antibodies 18 to 30-fold, regardless of vaccination platforms and age groups. Used as a primary vaccine, the Sanofi-GSK vaccine was inoculated in two doses, and then an additional booster dose was performed, neutralizing antibodies increased from 84 to 153 times the pre-booster levels. figures 1a and 1b). “We are very pleased with these data, which confirm our scientific approach and the benefits of our COVID-19 vaccine. – said Thomas Triomphe, Executive Vice President, Sanofi Vaccines Division – The Sanofi-GSK vaccine demonstrates a universal ability to enhance antibodies. regardless of the vaccination platforms of the primary vaccination and in all ages.We also observed a robust efficacy of the vaccine used as a primary cycle vaccine, despite the current complex epidemiological context. No other global phase 3 efficacy study has been undertaken in this period in which there are so many variants circulating (including Omicron). The efficacy data are very similar to the recent clinical data of already authorized vaccines. “” The constantly evolving epidemiological situation of COVID-19 demonstrates the need for a variety of vaccines. Our adjuvanted protein vaccine candidate uses a well-established approach that has been widely applied to prevent infection with other viruses, including influenza. We are confident that this vaccine can play an important role as we continue to tackle this pandemic and prepare for the post-pandemic period. “- added Roger Connor, president of GSK, vaccines division. When used as a two-dose primary vaccine, the Sanofi-GSK vaccine showed solid levels of neutralizing antibodies, with GMTs reaching 3711 units. For comparison, a panel of sera from volunteers in the same age group who received two doses of an already approved and highly effective mRNA vaccine showed a GMT of 1653 units, measured simultaneously in the same laboratory. Data from the VAT08 efficacy study showed that two doses of Sanofi-GSK vaccine showed 57.9 percent efficacy (95 percent confidence interval [CI, 26.5, 76.7]) against any symptomatic COVID disease. -19 in the seronegative population. The Sanofi-GSK vaccine provided 100 percent protection (0 vs 10 cases post-dose 1, 0 vs 4 post-dose cases 2) against severe disease and hospitalizations and 75 percent (3 vs 11 cases) efficacy against moderate to severe disease in seronegative populations. While sequencing is still ongoing, early data indicate 77 percent efficacy against any symptomatic COVID-19 disease associated with the Delta variant, in line with the vaccine’s expected efficacy. In both studies, the Sanofi-GSK vaccine was well tolerated in younger and older adults, with no safety concerns. The companies are in discussions with regulatory authorities, including the US FDA and the European Medicines Agency (EMA), and plan to submit the full data generated with this vaccine candidate to support regulatory clearances. The Phase 3 study, VAT08, is evaluating a 10 µg antigen formulation of the adjuvant SARS-CoV-2 vaccine based on recombinant proteins for efficacy, immunogenicity and safety versus a placebo. The first phase of the trial is evaluating the efficacy of a vaccine formulation containing the spike protein against the original (parental) virus D614 in more than 10,000 participants aged> 18 years, randomized to receive two doses of 10 µg vaccine or placebo. on day 1 and day 22 at sites in the United States, Asia, Africa and Latin America. Enrollment was recently completed for a second phase of the trial, evaluating a second bivalent formulation, including variant spike protein B.1.351 (Beta). The Phase 3 trial follows the initial positive results of a Phase 2 clinical trial (VAT00002). In that study, the COVID-19 vaccine candidate was administered to 722 adults to evaluate the safety, reactogenicity and immunogenicity of 2 doses and to identify an optimal dosage to use as a booster. The results showed strong neutralizing antibody response rates with seroconversion of 95 percent to 100 percent after a second injection in all age groups (18 to 95 years), with all doses. Full study results for both VAT08 and VAT02 will be published in the coming months of this year. These efforts are supported by federal funding from the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary of Preparation and Response at the United States Department of Health and Human Services in conjunction with the United States Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under contract # W15QKN-16- 9-1002 and the National Institute of Allergy and Infectious Diseases (NIAID). The NIAID provides grants to the HIV Vaccine Trials Network (HVTN) Leadership and Operations Center (UM1 AI 68614HVTN), the Statistics and Data Management Center (UM1 AI 68635), the HVTN Laboratory Center (UM1 AI 68618), the ‘HIV Prevention Trials Network Leadership and Operations Center (UM1 AI 68619), AIDS Clinical Trials Group Leadership and Operations Center (UM1 AI 68636), and the Infectious Diseases Clinical Research Consortium (UM1 AI 148684, UM1 AI 148450, UM1 AI 148372, UM1 AI 148574). In the collaboration between the two companies, Sanofi makes its recombinant antigen available and GSK contributes its pandemic adjuvant, both well-established vaccine platforms that have proven to be successful against influenza already.
