Much buzz was created around the world when Russia claimed to have approved the first COVID-19 vaccine around the world, for public use. Experts and researchers from around the world questioned the efficacy and safety of the vaccine, dubbed as Sputnik V.
However, according to reports, a small early trial study has found that the Russian vaccine is both effective against the novel coronavirus and can produce an immune response, and at the same time, may also be safe.
According to a report by news agency AFP, details of the early tests on Russian COVID-19 vaccine were published on Friday and seemed encouraging. However, experts have expressed their apprehensions on the sample size of these trials, saying that they were too small to prove effectiveness and safety.
In the study published in the Lancet, researchers from Russia reported on two small trials conducted with the Sputnik V. It involved 38 healthy adults between the age of 18 and 60. They were given a two-part immunisation. Each participant was given a dose of the first part of the vaccine, and then a booster with the second part, 21 days later, AFP reported. These volunteers were monitored over 42 days, and it was found that all of them developed antibodies against the virus within three weeks.
The Lancet report further declared the vaccine as “Safe, well-tolerated, and does not cause serious adverse events in healthy adult volunteers.”
The trials were open-label and not randomised. However, among other concerns, researchers have also said that larger, longer, and randomised trials may be required to establish the long-term safety and efficacy of the vaccine.
The report said the 76 participants of these trials would be monitored up to 180 days, adding that a more rigorous phase 3 clinical trial was planned with the involvement of 40,000 volunteers “from different age and risk groups”.
Russia has said that industrial production of Sputnik V is expected from September, and a mass-vaccination is also planned in October, this year.
President Vladimir Putin in early August said that the vaccine gave “sustainable immunity”. One of his daughters had also been inoculated, on the day when the vaccine approval was announced, even though Russia’s health ministry said clinical trials were not yet complete.
Apart from experts, even the WHO has requested Russia to follow guidelines laid down by the health agency to develop a safe vaccine, wherein it must go through all the stages of the trial to be finally approved.
Sputnik V was developed by the Gamaleya research institute for epidemiology and microbiology in Moscow in coordination with the Russian defence ministry.
