PARIS: Sanofi and GSK recently announced that they intend to submit data from both their booster and Phase 3 efficacy trials as the basis for regulatory applications for a COVID-19 vaccine.
The Phase 3 trial, VAT08, follows a positive initial Phase 2 clinical trial (VAT00002) results. Data from the VAT08 efficacy study showed that two doses of the Sanofi-GSK vaccine generated 100 per cent efficacy against severe COVID-19 disease and hospitalizations, 75 per cent efficacy against moderate or severe COVID-19 disease and 57.9 per cent efficacy against any symptomatic COVID-19 disease, in line with the expected vaccine effectiveness in today’s environment dominated by variants of concern. Moreover, 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 European Medicines Agency (EMA), and plan to submit the totality of the data generated with this vaccine candidate to support regulatory authorizations.
However, full study results for both VAT08 and VAT02 will be published later this year.
