Sputnik V is a COVID-19 vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology. An interim analysis from the trial that was published in the Lancet indicating 91.6% efficacy without unusual side-effects. Sputnik V uses a heterologous recombinant adenovirus approach utilizing adenovirus 26 (Ad26) and adenovirus 5 (Ad5) as vectors for the expression of SARS-CoV-2 spike (S) protein.
Sputnik V uses a weakened virus to deliver small parts of a pathogen and induce an immune response. It is a vector vaccine based on adenovirus deoxyribonucleic acid (DNA), wherein the SARS-CoV-2 gene is integrated. The late-stage trial or phase 3 trial involved 21,977 adults randomly assigned to the vaccine or placebo groups.
Of these, 19,866 received two doses of the vaccine or placebo and were included in the primary outcome analysis. The vaccine, wherein the first dose is the rAd26 and the second dose is the rAd5 or placebo, was administered intramuscularly into the deltoid muscle with a 21-day interval between doses. Of the 14,964 people in the vaccine group, only 16 had developed symptomatic cases of COVID-19 after receiving the second dose of the vaccine. In the placebo group, however, 62 were infected in the 4,902-strong placebo group. Hence, the vaccine efficacy was computed at 91.6 percent. The observed vaccine efficacy was greater than 87 percent in all age and sex subgroups.
Also, vaccine efficacy was 91.8 percent in participants who are older than 60 years. In terms of adverse effects, most of the reported cases were mild or grade 1. Meanwhile, 45 participants of the vaccine group and 23 of the placebo group had serious adverse events. None were considered linked to vaccination.
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