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Home Sanofi and GSK Announce Positive Phase 3 and Booster Trial Data for Their Adjuvanted Recombinant COVID-19 Vaccine Candidate

Sanofi and GSK Announce Positive Phase 3 and Booster Trial Data for Their Adjuvanted Recombinant COVID-19 Vaccine Candidate

Feb 24, 2022 00:25 CST Updated 00:25
GSK

Pharmaceutical R&D Manufacturer

Sanofi

Pharmaceutical R&D Developer


News on February 23, 2022 /BioValleyBIOON/ -- According to Baidu's "Real-time Updates on the COVID-19 Pandemic"Big DataReport》，As of 22:00 on February 23, 2022, the global cumulative confirmed cases exceeded 420 million (428.77 million), with over 5.92 million deaths.

GlaxoSmithKline PLC.GSK and Sanofi recently announced jointly that they will submit the final data of the global VAT02 booster trial of the Sanofi-GSK vaccine, as well as the data from the Phase 3 VAT08 primary series efficacy trial, to support the regulatory authorization of this COVID-19 vaccine.

The public health relevance of the Sanofi-GSK vaccine, which stabilizes adjuvant proteins at refrigerator temperatures, is strongly supported by robust induction of immune responses and a favorable safety profile across diverse settings.

Final analysis data from the global VAT02 booster trial shows,In subjects who have received a series of authorized mRNA or adenovirus vaccines as primary immunization, the Sanofi-GSK booster vaccine induced neutralizing antibody levels that were significantly increased by 18-30 times across various vaccine platforms and age groups.. WhenSanofi-GSK vaccine is used for two-dose primary vaccination, followed by a booster dose, which increased neutralizing antibody levels by 84-153 times compared to pre-booster levels.(See Figures 1a and 1b below).

When used for two-dose primary vaccination, the Sanofi-GSK vaccine induces high levels of neutralizing antibodies, with a GMT reaching 3,711 units. For comparison, a set of sera from volunteers of the same age group who had received two doses of an approved highly effective mRNA vaccine was measured simultaneously in the same laboratory, showing a GMT of 1,653 units.

VAT02 Booster Trial Data (Click image to enlarge)

Data from the VAT08 Phase 3 basic immunization efficacy trial show,In seronegative populations, the efficacy of two doses of the Sanofi-GSK vaccine in preventing any symptomatic COVID-19 disease is 57.9%.(95% CI: 26.5, 76.7). In the seronegative population, the Sanofi-GSK vaccineThe effective rate for preventing severe cases and hospitalization is 100%.(After the 1st dose: 0 cases vs 10 cases; After the 2nd dose: 0 cases vs 4 cases),The efficacy rate for preventing moderate to severe disease is 75%.(3 cases vs 11 cases). Although sequencing is still ongoing, early data suggests consistency with the expected vaccine efficacy.The effectiveness rate in preventing any symptomatic COVID-19 disease related to the Delta variant reached 77%.。

In these two studies, the Sanofi-GSK vaccine was well tolerated as a two-dose primary series and as a single booster dose in both younger and older adults, with no safety concerns.

GlaxoSmithKline PLC.In collaboration with Sanofi, including the United StatesFDADiscussions with regulatory agencies, including the EU EMA, are underway, and there are plans to submit all data generated by the Sanofi-GSK vaccine to support regulatory authorization. (Bioon.com)