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Sanofi and GSK begin new study of their COVID-19 vaccine


The new Phase II study will involve 720 volunteers aged 18 years and over, and will include equal numbers of adults aged 18 to 59 years and those 60 years and above. The study will test three different antigen doses with a fixed dose of adjuvant in the total study population, at sites in the US, Honduras and Panama. Sanofi/GSK said in a statement that results of the Phase II trial will inform the Phase III protocol, adding that if data from the new trial is positive, a global late-stage trial could begin in the second quarter of 2021. Depending on the outcome of the potential Phase III trial, regulatory submissions for the vaccine could be expected in the second half of 2021, with the vaccine likely to then be available in Q4 2021 if approved.

PharmaTimes - February 23, 2021

View the full story here: http://www.pharmatimes.com/news/sanofi_and_gsk_begin_new_study_of_their_covid-19_vaccine_1363891