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Russian vaccine Sputnik V is 91.6% effective against covid-19 in its symptomatic manifestations, according to an analysis of clinical trials published Tuesday by the medical journal The Lancet and validated by independent experts.
Preliminary results consider that the vaccine, administered in two doses, “showed great efficacy” and was well tolerated by volunteers over 18 years old who participated in the final stage of clinical trials, said Inna Dolzhikova, researcher at the Gamaleya National Center in Russia and co-author of the study.
Another sub-study carried out on more than 2000 adults over 60 years has shown that the vaccine has in them an efficiency of 91.8%. In this subgroup, the drug was well tolerated and safety data from 1369 of these elderly people showed that the most common side effects were flu symptoms.
The full article in The Lancet
How did the clinical trial go?
The study in people over 18 was conducted in 25 Moscow hospitals and polyclinics with 21,977 volunteers who, between September 7 and November 24, received Sputnik V or a random placebo. According to data published by The Lancet, 19,866 people received two doses of the vaccine or placebo and they were taken into account in the first results of the analyzes.
On the day the volunteers were due to receive the second dose, 16 (0.1%) of 14,964 participants who received Sputnik V developed coronavirus, while 62 (1.3%) of 4,902 people who received placebo contracted illness during this period of time.
The article notes that no significant side effects were detected in the study. Only 45 (0.3%) of the 16,427 volunteers who received the vaccine had serious adverse effects, although none are related to vaccination. In addition, four deaths were reported during the study (only three of those people had received the drug) and, according to the monitoring committee, none were related to Sputnik V.
“This is a great achievement in the global fight against the covid-19 pandemic”
Although this is an interim review of the Phase III randomized controlled trial, different researchers have celebrated these results. “Sputnik V’s development has been criticized for its speed and lack of transparency British virologists and professors Ian Jones and Polly Roy recalled in The Lancet. But the result that we report here is clear and the scientific principle of vaccination is proven, which means that another vaccine can join the fight to reduce the incidence of covid-19 ”.
For his part, Alexander Gintsburg, director of the Gamaleya Institute, stressed that the data from the trial demonstrate the safety of Sputnik V and its high efficacy against the virus. “This is a great success in the global fight against the covid-19 pandemic,” he celebrated.
The average efficacy of Sputnik V is similar to that of vaccines developed by pharmaceutical companies Moderna and Pfizer / BioNTech, which are around 95%.
Sputnik V in the world
The vaccine created by the Gamaleya Institute has been authorized – in addition to Russia – in 14 countries, including Argentina, Hungary, Algeria, Serbia, Bolivia, Venezuela, Paraguay, Turkmenistan, Belarus, Kazakhstan, United Arab Emirates and Iran. And the Czech Republic, Mexico and Sri Lanka have taken an interest in it.
Meanwhile, the clinical trial in Russia continues with around 40,000 volunteers.
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