Sanofi, GSK To Seek Authorization For COVID-19 Vaccine Based On Data From Booster & Efficacy Trials

(RTTNews) - Sanofi (SNYNF, SNY) and GSK (GSK.L, GSK) said they plan to submit data from both their booster and phase 3 efficacy trials as the basis for regulatory applications for a COVID-19 vaccine. Data from the VAT08 efficacy study showed that two doses of Sanofi-GSK vaccine generated an efficacy of 57.9% against any symptomatic COVID-19 disease in the seronegative population. The Sanofi-GSK vaccine provided 100% protection against severe disease and hospitalizations and 75% efficacy against moderate-to-severe disease in seronegative populations.

The companies said 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.

The companies are in talks with regulatory authorities and plan to submit the totality of the data generated with this vaccine candidate to support regulatory authorizations.