Interim analysis of the randomized, double-blind, placebo-controlled phase 3 trial for the recombinant adenovirus (rAd)-based vaccine Gam-COVID-Vac (Sputnik V) (n=19,866) showed an efficacy of 91.6% (CI: 85.6%-95.2%) by 21 days after the first dose of vaccine (the day of dose 2). 16 of 14,964 (0.1%) people in the vaccine group developed COVID-19 compared to 62 of 4,902 (1.3%) people in the placebo group. Participants were required to be IgG\/IgM negative at baseline for enrollment. Rates of disease onset were similar for the vaccine and placebo groups until about 16 to 18 days after the first dose.<\/p>\n
The observed vaccine efficacy was > 87% in all age and sex subgroups (60% male), and 91.8% in participants aged >60 years (11% of participants). 98.5% of participants were white, and the entire study was conducted in 25 hospitals and polyclinics in Moscow, Russia. 94% of reported adverse events were grade 1, with 0.3% and 0.4% of vaccine and placebo group experiencing serious adverse events, respectively.\u00a0<\/span><\/p>\n Logunov et al. (Feb 2, 2021). Articles Safety and Efficacy of an RAd26 and RAd5 Vector-Based Heterologous Prime-Boost COVID-19 Vaccine: An Interim Analysis of a Randomised Controlled Phase 3 Trial in Russia. The Lancet. <\/i>https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(21)00234-8\/fulltext<\/a>\u00a0<\/span><\/i><\/p>\n","protected":false},"excerpt":{"rendered":" Interim analysis of the randomized, double-blind, placebo-controlled phase 3 trial for the recombinant adenovirus (rAd)-based vaccine Gam-COVID-Vac (Sputnik V) (n=19,866) showed an efficacy of 91.6% (CI: 85.6%-95.2%) by 21 days after the first dose of vaccine (the day of dose 2). 16 of 14,964 (0.1%) people in the vaccine group developed COVID-19 compared to 62…<\/p>\n