Shots:

• The P-III COMET-TAIL trial evaluates the efficacy, safety & tolerability of sotrovimab (250/500mg, given as IM compared to IV) in 983 high-risk patients aged =12yrs. with COVID-19 for 7 days after symptom onset. This trial is based on the results of a P-III COMET-ICE trial
• The trial meet its 1EPs i.e, sotrovimab (IM) was non-inferior & offered similar efficacy to IV administration for high-risk populations, 2.7% rate of progression to hospitalization for 24+ hrs. or death @29 days vs 1.3% in the IV administration in 500mg dose
• The companies plan for regulatory submissions globally in Q1'22 including ongoing FDA discussions. Sotrovimab is an investigational SARS-CoV-2 neutralizing mAb

 Ref: GSK | Image: GSK