Ella R, Reddy S, Blackwelder W, et al. - The clinical efficacy of BBV152, a whole virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG), against COVID-19 infection has been investigated in Indian adults.

• Researchers conducted a randomized, double-blind, placebo-controlled, multicenter, phase 3 clinical trial in 25 Indian hospitals or medical clinics.

• A total of 25,798 participants were randomly assigned to receive BBV152 or placebo; 24,419 received two intramuscular doses of BBV152 (n = 12,221) or placebo (n = 12,198) administered 4 weeks apart.

• There occurred a total of 24 (0·3%) cases among 8,471 vaccine recipients and 106 (1·2%) among 8,502 placebo recipients, giving an overall estimated vaccine efficacy of 77·8% (95% CI 65·2–86·4).

• Based on the findings, BBV152 is supported as highly efficacious against laboratory-confirmed symptomatic COVID-19 disease in adults.

• Participants showed good tolerability towards vaccination with no safety concerns raised in this interim analysis.