An interim analysis of data from a phase 3 clinical trial of Russia’s two-dose Gam-COVID-Vac (Sputnik V) coronavirus vaccine involving nearly 20,000 adult volunteers suggests an efficacy of 91.6% against symptomatic infection. In the randomized, controlled, double-blind study, published today in The Lancet, researchers from the Ministry of Health of the Russian Federation in Moscow randomly assigned 19,866 participants at 25 hospitals and clinics in a 3:1 ratio to receive either the adenovirus-based vaccine or a placebo from Sep 7 to Nov 24, 2020. A 0.5-milliliter (mL) dose was given, followed by a second dose 21 days later. High efficacy in older recipients After the second dose, 16 of 14,964 (0.1%) of vaccine group participants tested positive for COVID-19, versus 62 of 4,902 (1.3%) in the placebo group. The observed vaccine effectiveness was higher than 87% in all age and sex subgroups, including a 91.8% efficacy in volunteers older than 60 years. Fifteen to...
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