Conclusions
In this multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trial, the study findings indicate that the FINLAY-FR-2 vaccine, in addition to the third dose of FINLAY-FR-1A, has acceptable VE against symptomatic cases and high efficacy against severe cases of COVID-19 and COVID-19–related hospitalizations. FINLAY-FR-2 and FINLAY-FR-1A also appeared to be well tolerated and have a favorable safety profile.