Sanofi and GSK Initiate P-III Clinical Study of their COVID-19 Vaccine
Shots:
- The companies have started enrollment of patients in a P-III clinical study to assess the safety- efficacy & immunogenicity of COVID-19 vaccine candidate vs PBO in 35-000+ volunteers aged ≥ 18yrs. from multiple countries including the US
- The 1EP& 2EP of the study is to prevent symptomatic & asymptomatic infection respectively. A two-stage study is designed to assess the efficacy of vaccine targeting D.614 virus & B.1.351 variant in diverse geographies with multiple circulating variants
- The booster study is expected to be initiated in the coming wks. to complement the P-III study. The company is expecting the approval of the vaccine in Q4’21- manufacturing will begin in the coming wks.
Ref: Globe Newswire | Image: Sanofi
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